BEUDAMED
    IVDR IVDR QMS Issued

    HX 2262557-1

    Manufacturer: Epocal Inc.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0

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    157
    Expires in 157 days
    Expiry: December 31, 2026

    Basic Information

    Number
    HX 2262557-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    June 10, 2023
    Expiry Date
    December 31, 2026
    Revision
    Rev.0
    Manufacturer
    Epocal Inc.

    Certificate Lifecycle

    June 10, 2023 December 31, 2026

    Scopes

    Quality Procedure Scope

    Device Group Class C

    W01010804 - Multiple Parameter Electrodes/Biosensors Multiple Blood Gas Only - Electrodes/Biosensors

    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.