BEUDAMED
    MDR MDR QMS Issued

    IT335406

    Manufacturer: Calopad AG
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    1184
    Valid for 1184 days
    Expiry: September 3, 2029

    Basic Information

    Number
    IT335406
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 4, 2024
    Expiry Date
    September 3, 2029
    Revision
    1
    Manufacturer
    Calopad AG

    Certificate Lifecycle

    September 4, 2024 September 3, 2029

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Cryotherapy and thermoterapy devices MDA 0303 - Active non-implantable devices utilising hyperthermia / hypothermia

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    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.