BEUDAMED
    MDR MDR QMS

    HZ 1550682-1

    Manufacturer: Oxipit, UAB
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    2
    258
    Valid for 258 days
    Expiry: February 22, 2027

    Basic Information

    Number
    HZ 1550682-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 15, 2024
    Expiry Date
    February 22, 2027
    Revision
    2
    Manufacturer
    Oxipit, UAB

    Certificate Lifecycle

    February 15, 2024 February 22, 2027

    Scopes

    Quality Procedure Scope

    Device Group Class IIb

    Z129082 - Various functionalities exploring and treatment instruments – software - Standalone computer assisted diagnostic medical device software for chest X-ray images analysis and reporting

    Preceding Certificates

    HZ 1550682-1 Issued
    Issued: February 23, 2022 Expires: December 22, 2025

    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.