BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2063387-1

    Manufacturer: Ningbo Huakun Medical Equipment Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    1
    Revision
    2
    204
    Valid for 204 days
    Expiry: December 29, 2026

    Basic Information

    Number
    HZ 2063387-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 27, 2024
    Expiry Date
    December 29, 2026
    Revision
    2
    Manufacturer
    Ningbo Huakun Medical Equipment Co., Ltd.

    Certificate Lifecycle

    November 27, 2024 December 29, 2026

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Sterile

    R010102 - GUEDEL AIRWAY TUBES R018002 - INTUBATION DEVICE SUPPORTS

    Quality Procedure Scope

    Device Group Class IIa

    R020199 - BREATHING CIRCUITS AND KITS – OTHER R030101 - VENTILATION MASKS R040199 - VENTILATION FILTERS – OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) R010201 - LARYNGEAL MASKS R060101 - COLD NEBULISATION SYSTEMS R010302 - ENDOTRACHEAL TUBES, CUFFED R010301 - ENDOTRACHEAL TUBES, CUFFLESS

    Preceding Certificates

    HZ 2063387-1 Issued
    Issued: July 31, 2023 Expires: December 29, 2026

    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.