BEUDAMED
    MDR MDR QMS Issued

    HZ 1623480-1

    Manufacturer: Wellell Inc.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0

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    1239
    Valid for 1239 days
    Expiry: December 16, 2029

    Basic Information

    Number
    HZ 1623480-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 17, 2024
    Expiry Date
    December 16, 2029
    Manufacturer
    Wellell Inc.

    Certificate Lifecycle

    December 17, 2024 December 16, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class IIa

    R030101 - VENTILATION MASKS

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.