BEUDAMED
    MDR MDR QA Issued

    DZ 2138755-1

    Manufacturer: United Dental Changzhou
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    750
    Valid for 750 days
    Expiry: June 27, 2028

    Basic Information

    Number
    DZ 2138755-1
    Type
    MDR QA
    Legislation
    MDR
    Issue Date
    June 28, 2023
    Expiry Date
    June 27, 2028
    Manufacturer
    United Dental Changzhou

    Certificate Lifecycle

    June 28, 2023 June 27, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Q010507 - ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE L159004 - ENDODONTIC RASPS AND FILES, REUSABLE

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L159004 - ENDODONTIC RASPS AND FILES, REUSABLE

    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.