BEUDAMED
    MDR MDR QMS Issued

    MDR-0017

    Manufacturer: VitalThings AS
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    1209
    Valid for 1209 days
    Expiry: September 30, 2029

    Basic Information

    Number
    MDR-0017
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 1, 2024
    Expiry Date
    September 30, 2029
    Revision
    1
    Manufacturer
    VitalThings AS

    Certificate Lifecycle

    October 1, 2024 September 30, 2029

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Multi-parameter patient bedside monitors

    Quality Procedure Scope

    Device Group Class IIb

    Transportable/Portable Multi-parameter patient monitors

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    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.