BEUDAMED
    MDR MDR QMS Issued

    HZ 2502508-1

    Manufacturer: EMSRUN GROUP
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1152
    Valid for 1152 days
    Expiry: August 4, 2029

    Basic Information

    Number
    HZ 2502508-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 5, 2024
    Expiry Date
    August 4, 2029
    Manufacturer
    EMSRUN GROUP

    Certificate Lifecycle

    August 5, 2024 August 4, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    A019009 - DRAINAGE NEEDLES R010102 - GUEDEL AIRWAY TUBES

    Quality Procedure Scope

    Device Group Class I Sterile

    M020101 - COTTON GAUZES, CUT M030301 - ELASTIC FIXING BANDAGES M0499 - SPECIAL DRESSINGS - OTHER

    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.