BEUDAMED
    MDR MDR QMS Issued

    TNP/MDR/0018/3830/2024

    Manufacturer: FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    1
    Revision
    Ver. 01
    291
    Valid for 291 days
    Expiry: March 27, 2027

    Basic Information

    Number
    TNP/MDR/0018/3830/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 28, 2024
    Expiry Date
    March 27, 2027
    Revision
    Ver. 01
    Manufacturer
    FOLDIX MEDICAL INŻ. UWE WERNER PETRASCH

    Certificate Lifecycle

    March 28, 2024 March 27, 2027

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class I Sterile

    Osłony foliowe do kamer medycznych / Foil covers for medical cameras

    Quality Procedure Scope

    Device Class I Sterile

    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.