BEUDAMED
    MDR MDR QMS Supplemented

    007-00-03-MDR

    Manufacturer: BIOTEC S.R.L.
    Basic UDI-DIs
    0
    Scopes
    18
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    03
    559
    Valid for 559 days
    Expiry: December 20, 2027

    Basic Information

    Number
    007-00-03-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 31, 2024
    Expiry Date
    December 20, 2027
    Revision
    03
    Manufacturer
    BIOTEC S.R.L.

    Certificate Lifecycle

    May 31, 2024 December 20, 2027

    Device Characteristics

    Sterile

    Scopes

    18 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIb Class IIa

    Dental implants and dental materials

    Quality Procedure Scope

    Device Group Class IIa

    Non-active non-implantable instruments

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    007-00-02-MDR Amended
    Issued: July 27, 2023 Expires: December 20, 2027

    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.