BEUDAMED
    MDR MDR QMS Issued

    HZ 2033753-1

    Manufacturer: DRTECH Corporation
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    Rev.0
    1191
    Valid for 1191 days
    Expiry: September 11, 2029

    Basic Information

    Number
    HZ 2033753-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 12, 2024
    Expiry Date
    September 11, 2029
    Revision
    Rev.0
    Manufacturer
    DRTECH Corporation

    Certificate Lifecycle

    September 12, 2024 September 11, 2029

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z110311 - DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS

    Quality Procedure Scope

    Device Group Class IIb

    Z110311- DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES

    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.