BEUDAMED
    MDR MDR QMS Issued

    FI23/00000033

    Manufacturer: Sooma Oy
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 1
    812
    Valid for 812 days
    Expiry: August 29, 2028

    Basic Information

    Number
    FI23/00000033
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 30, 2023
    Expiry Date
    August 29, 2028
    Revision
    Issue 1
    Manufacturer
    Sooma Oy

    Certificate Lifecycle

    August 30, 2023 August 29, 2028

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Neurological stimulator

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    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.