BEUDAMED
    MDR MDR QMS Supplemented

    FI22/00000011

    Manufacturer: Icare Finland Oy
    Basic UDI-DIs
    0
    Scopes
    15
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    Issue 4
    488
    Valid for 488 days
    Expiry: October 9, 2027

    Basic Information

    Number
    FI22/00000011
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 23, 2024
    Expiry Date
    October 9, 2027
    Revision
    Issue 4
    Manufacturer
    Icare Finland Oy

    Certificate Lifecycle

    August 23, 2024 October 9, 2027

    Scopes

    15 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Tonometers, Z12120122

    Quality Procedure Scope

    Device Group Class IIa

    Software accessories for Tonometers, Z12120182

    Quality Procedure Scope

    Device Group Class IIa

    Measurement devices - other, V0399

    Quality Procedure Scope

    Device Group Class IIa

    Medical device software - not included in other classes, V92

    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 IIa

    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 IIa

    Preceding Certificates

    FI22/00000011
    Issued: August 10, 2023 Expires: October 9, 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.