BEUDAMED
    MDR MDR QMS Issued

    HZ 2100551-1

    Manufacturer: MANI, INC.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    Rev.2
    1066
    Valid for 1066 days
    Expiry: May 9, 2029

    Basic Information

    Number
    HZ 2100551-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 13, 2024
    Expiry Date
    May 9, 2029
    Revision
    Rev.2
    Manufacturer
    MANI, INC.

    Certificate Lifecycle

    September 13, 2024 May 9, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L159004 - ENDODONTIC RASPS AND FILES, REUSABLE Q010199 - CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER L159012 - ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use

    Quality Procedure Scope

    Device Group Class IIa

    Q020101 - OPHTHALMIC MICROKNIVES Q021113 - OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE Q020199 - OPHTHALMIC CUTTING DEVICES - OTHER Q021101 - OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE Q021102 - OPHTHALMIC SURGERY FORCEPS, SINGLE USE L159004 - ENDODONTIC RASPS AND FILES, REUSABLE L159007 - ODONTOSTOMATOLOGY BURS, REUSABLE Q010102 - ROOT CANAL FILLING DEVICES

    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.