BEUDAMED
    MDR MDR QMS Issued

    HZ 2438964-1

    Manufacturer: Shandong Shinrise Medical Supplies Co., LTD
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1261
    Valid for 1261 days
    Expiry: November 21, 2029

    Basic Information

    Number
    HZ 2438964-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 22, 2024
    Expiry Date
    November 21, 2029
    Manufacturer
    Shandong Shinrise Medical Supplies Co., LTD

    Certificate Lifecycle

    November 22, 2024 November 21, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    M040402 - ALGINATE DRESSINGS M040403 - HYDROCOLLOID DRESSINGS M040406 - POLYURETHANE DRESSINGS

    Quality Procedure Scope

    Device Group Class I Sterile

    M010101 - HYDROPHILIC COTTON M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD M040406 - POLYURENTHANE DRESSINGS T020101 - INCISION DRAPES

    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.