BEUDAMED
    MDR MDR QMS Issued

    2022-MDR/QS-027

    Manufacturer: CHIRANA T.Injecta, a.s.
    Basic UDI-DIs
    0
    Scopes
    12
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    478
    Valid for 478 days
    Expiry: September 30, 2027

    Basic Information

    Number
    2022-MDR/QS-027
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 30, 2022
    Expiry Date
    September 30, 2027
    Revision
    00
    Manufacturer
    CHIRANA T.Injecta, a.s.

    Certificate Lifecycle

    September 30, 2022 September 30, 2027

    Device Characteristics

    Sterile

    Scopes

    12 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Non-active and Non-implantable Medical Devices: Tubular Devices

    Quality Procedure Scope

    Device Group Class IIa

    Non-active and Non-implantable Medical Devices: Adapters, Connectors, Ramps, Stopcock, Caps

    Quality Procedure Scope

    Device Group Class IIa

    Non-active and Non-implantable Medical Devices: Arterio-Venous System Devices

    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

    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.