BEUDAMED
    MDR MDR QMS Issued

    1434-MDR-002/2024

    Manufacturer: OASIS Diagnostics S.A.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1/22.03.2024/ Nr S/066/BM/2023, Nr S/067/BM/2023
    1019
    Valid for 1019 days
    Expiry: March 24, 2029

    Basic Information

    Number
    1434-MDR-002/2024
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 22, 2024
    Expiry Date
    March 24, 2029
    Validity Start
    March 25, 2024
    Revision
    1/22.03.2024/ Nr S/066/BM/2023, Nr S/067/BM/2023
    Manufacturer
    OASIS Diagnostics S.A.

    Certificate Lifecycle

    March 22, 2024 March 24, 2029

    Device Characteristics

    Intended Medical Purpose

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    U0899 - GYNAECOLOGICAL DEVICES - OTHER

    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.