BEUDAMED
    MDR MDR QMS Issued

    TNP/MDR/0023/5338/2024

    Manufacturer: UNITRA Sp. z o.o.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Ver. 01
    451
    Valid for 451 days
    Expiry: September 2, 2027

    Basic Information

    Number
    TNP/MDR/0023/5338/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 3, 2024
    Expiry Date
    September 2, 2027
    Revision
    Ver. 01
    Manufacturer
    UNITRA Sp. z o.o.

    Certificate Lifecycle

    September 3, 2024 September 2, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    Urządzenie wspomagające manualną resuscytację / Device supporting manual resuscitation

    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.