BEUDAMED
    MDR MDR QMS Issued

    2022-MDR/QS-002

    Manufacturer: HEALTHIUM MEDTECH LIMITED
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    358
    Valid for 358 days
    Expiry: June 2, 2027

    Basic Information

    Number
    2022-MDR/QS-002
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 2, 2022
    Expiry Date
    June 2, 2027
    Revision
    00
    Manufacturer
    HEALTHIUM MEDTECH LIMITED

    Certificate Lifecycle

    June 2, 2022 June 2, 2027

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    Sterile Latex Surgical Gloves - Pre Powdered Sterile Latex Surgical Gloves - Powder Free

    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.