BEUDAMED
    MDR MDR QMS Supplemented

    CR-03-1004-836-24

    Manufacturer: GE Healthcare Finland Oy
    Basic UDI-DIs
    0
    Scopes
    35
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    02
    244
    Valid for 244 days
    Expiry: February 8, 2027

    Basic Information

    Number
    CR-03-1004-836-24
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 4, 2024
    Expiry Date
    February 8, 2027
    Revision
    02
    Manufacturer
    GE Healthcare Finland Oy

    Certificate Lifecycle

    July 4, 2024 February 8, 2027

    Scopes

    35 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    MDA 0315 Software

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters

    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 IIb

    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 IIb

    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 IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIa

    MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care.

    Quality Procedure Scope

    Device Class IIa

    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 IIb

    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 IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    CR-03-1004-836-24 Supplemented
    Issued: February 22, 2024 Expires: February 8, 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.