BEUDAMED
    MDR MDR QMS Issued

    HZ 2186867-1

    Manufacturer: Zhejiang Top-medical Medical Dressing Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    3
    Characteristics
    1
    Revision
    0

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    437
    Valid for 437 days
    Expiry: October 6, 2027

    Basic Information

    Number
    HZ 2186867-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 26, 2022
    Expiry Date
    October 6, 2027
    Manufacturer
    Zhejiang Top-medical Medical Dressing Co., Ltd.

    Certificate Lifecycle

    October 26, 2022 October 6, 2027

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    M04040301 - HYDROCOLLOID DRESSINGS, NON-COMBINED M04040201 - ALGINATE DRESSINGS, NON-COMBINED M04040601 - POLYURETHANE DRESSINGS, NON-COMBINED A06010101 - DRAINAGE SYSTEMS WITH PREDEFINED SUCTION

    Quality Procedure Scope

    Device Group Class IIb

    M04040701- SILICONE DRESSINGS, NON-COMBINED

    Quality Procedure Scope

    Device Group Class I Sterile

    M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD T02010101 - INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT

    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.