BEUDAMED
    MDR MDR QMS Supplemented

    FI24/00000041

    Manufacturer: Fimet Oy
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 2
    1080
    Valid for 1080 days
    Expiry: May 23, 2029

    Basic Information

    Number
    FI24/00000041
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 19, 2024
    Expiry Date
    May 23, 2029
    Revision
    Issue 2
    Manufacturer
    Fimet Oy

    Certificate Lifecycle

    September 19, 2024 May 23, 2029

    Conditions

    English

    Manufacturer shall complete the agreed additional evaluation and Post-Market Surveillance by end of year 2026.

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z12110101 Dental treatment units

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    FI24/00000041 Issued
    Issued: May 24, 2024 Expires: May 23, 2029

    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.