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    Sensores de oximetria de pulso

    Pediatric Disposable Pulse Oximetry Sensors

    Disposable pulse oximetry sensors for children. Comfort in re-positioning (soft medical grade tape). Less adhesive-related skin trauma where necessary – neonates, geriatric patients, patients with burn injuries and adapted for environment

    Overview

    EnviteC Cross Reference List   |   Tech Support

    Disposable SpO2 sensors for children. These sensors do not entail the risk of cross-contamination caused by medical products that are re-used from patient to patient.

    The high flexibility, adaptability and bio-compatibility of the applied soft material makes this sensor type ideal for applications where the patient needs extended long-term monitoring.

    EnviteC by Honeywell

    Certificado
    Name
    Description
    File Size
    Date
    Size
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.27 KB
    11/14/2025
    474.27 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/13/2025
    474.28 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.27 KB
    11/13/2025
    474.27 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfection of Returned Product(s)
    application/pdf 474.27 KB
    11/12/2025
    474.27 KB
    Others
    Name
    Description
    File Size
    Date
    Size
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.41 KB
    3/5/2026
    500.41 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 493.91 KB
    9/22/2021
    493.91 KB
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    3/10/2026
    492.27 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.27 KB
    3/5/2026
    500.27 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 493.91 KB
    9/22/2021
    493.91 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    application/pdf 496.49 KB
    3/10/2026
    496.49 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Instructions for Use
    Name
    Description
    File Size
    Date
    Size
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable pulse oximetry sensors
    application/pdf 17.46 MB
    8/21/2025
    17.46 MB
    Disposable pulse oximetry sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/12/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Name
    Description
    File Size
    Date
    Size
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.27 KB
    11/14/2025
    474.27 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.41 KB
    3/5/2026
    500.41 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/13/2025
    474.28 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 493.91 KB
    9/22/2021
    493.91 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    3/10/2026
    492.27 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    application/pdf 215.73 KB
    6/26/2024
    215.73 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    application/pdf 405.61 KB
    6/26/2024
    405.61 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.27 KB
    3/5/2026
    500.27 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 493.91 KB
    9/22/2021
    493.91 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.27 KB
    11/13/2025
    474.27 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    application/pdf 496.49 KB
    3/10/2026
    496.49 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable pulse oximetry sensors
    application/pdf 17.46 MB
    8/21/2025
    17.46 MB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    EC Certificate (MDD)
    EC Certificate (MDD)
    application/pdf 129.43 KB
    6/26/2024
    129.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    application/pdf 420.2 KB
    6/26/2024
    420.2 KB
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    application/pdf 340.29 KB
    6/26/2024
    340.29 KB
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    application/pdf 227.43 KB
    6/26/2024
    227.43 KB
    Disposable pulse oximetry sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/12/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    application/pdf 17.46 MB
    8/9/2024
    17.46 MB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    application/pdf 475.04 KB
    11/12/2025
    475.04 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    application/pdf 474.28 KB
    11/14/2025
    474.28 KB
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    application/pdf 500.42 KB
    3/5/2026
    500.42 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    application/pdf 492.27 KB
    9/22/2021
    492.27 KB
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfection of Returned Product(s)
    application/pdf 474.27 KB
    11/12/2025
    474.27 KB
    Name
    Description
    File Size
    Date
    Size
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.27 KB
    11/14/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.28 KB
    11/13/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.28 KB
    11/14/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Manufacturers Declaration according to EU MDR
    Manufacturers Declaration according to EU MDR
    215.73 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Confirmation Letter on validity of EC Certificate (MDD)
    Confirmation Letter on validity of EC Certificate (MDD)
    405.61 KB
    6/26/2024
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.27 KB
    11/13/2025
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.28 KB
    11/14/2025
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    EC Certificate (MDD)
    EC Certificate (MDD)
    129.43 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    Certificate MDSAP ISO 13485
    Certificate MDSAP ISO 13485
    420.2 KB
    6/26/2024
    Certificate According To ISO 13485 (English)
    Certificate According To ISO 13485 (English)
    340.29 KB
    6/26/2024
    Confirmation statement about company renaming
    Confirmation statement about company renaming
    227.43 KB
    6/26/2024
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (German)
    Form certificate on hygiene status and disinfection of returned product/s - German
    475.04 KB
    11/12/2025
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfectionof Returned Product(s)
    474.28 KB
    11/14/2025
    Form certificate on hygiene status and disinfection of returned product/s (English)
    Certificate of Hygiene Status and Disinfection of Returned Product(s)
    474.27 KB
    11/12/2025
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.42 KB
    3/5/2026
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.41 KB
    3/5/2026
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    492.27 KB
    9/22/2021
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.42 KB
    3/5/2026
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    493.91 KB
    9/22/2021
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    492.27 KB
    3/10/2026
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.27 KB
    3/5/2026
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    493.91 KB
    9/22/2021
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.42 KB
    3/5/2026
    Form details on potential safety relevant failures or events (English)
    Form details on potential safety relevant failures or events
    496.49 KB
    3/10/2026
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.42 KB
    3/5/2026
    Form details on potential safety relevant failures or events (German)
    Form details on potential safety relevant failures or events - German
    500.42 KB
    3/5/2026
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    492.27 KB
    9/22/2021
    Form details on potential safety relevant failures or events
    Form details on potential safety relevant failures or events
    492.27 KB
    9/22/2021
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/9/2024
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/9/2024
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/9/2024
    Disposable Pulse Oximetry Sensors
    Disposable pulse oximetry sensors
    17.46 MB
    8/21/2025
    Disposable pulse oximetry sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/12/2024
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/9/2024
    Disposable Pulse Oximetry Sensors
    Disposable Pulse Oximetry Sensors
    17.46 MB
    8/9/2024

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