BEUDAMED
    MDR MDR QMS Issued

    HZ 1753171-1

    Manufacturer: medentis medical GmbH
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    Rev. 0
    814
    Valid for 814 days
    Expiry: August 30, 2028

    Basic Information

    Number
    HZ 1753171-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 31, 2023
    Expiry Date
    August 30, 2028
    Revision
    Rev. 0
    Manufacturer
    medentis medical GmbH

    Certificate Lifecycle

    August 31, 2023 August 30, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Odontological Prostheses - P010201 - Dental Implants and Accessories

    Quality Procedure Scope

    Device Group Class I Sterile

    Q010207 - Dental Impression Devices for Prosthetic Dentistry The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions

    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.