BEUDAMED
    MDR MDR QMS Issued

    HZ 2175018-1

    Manufacturer: Suzhou Leapmed Healthcare Corporation
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0

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    1044
    Valid for 1044 days
    Expiry: June 6, 2029

    Basic Information

    Number
    HZ 2175018-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 7, 2024
    Expiry Date
    June 6, 2029
    Manufacturer
    Suzhou Leapmed Healthcare Corporation

    Certificate Lifecycle

    June 7, 2024 June 6, 2029

    Device Characteristics

    Sterile

    Scopes

    Quality Procedure Scope

    Device Group Class IIa

    019013 - PERCUTANEOUS NEEDLES - Disposable Puncture Needles A010201 - NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - Disposable Automatic Core Biopsy Instruments - Disposable Semi Automatic Biopsy Instruments - Disposable Coaxial Biopsy Needles - Disposable Biopsy Refill Needles

    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.