BEUDAMED
    MDR MDR QMS Issued

    28620117074

    Manufacturer: Agfa HealthCare NV
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0

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    28
    Expires in 28 days
    Expiry: August 24, 2026

    Basic Information

    Number
    28620117074
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 25, 2021
    Expiry Date
    August 24, 2026
    Manufacturer
    Agfa HealthCare NV

    Certificate Lifecycle

    August 25, 2021 August 24, 2026

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Software for imaging, radiology and clinical information

    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.