BEUDAMED
    MDR MDR QMS Issued

    HZ 2077760-1

    Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co.,Ltd
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1185
    Valid for 1185 days
    Expiry: September 5, 2029

    Basic Information

    Number
    HZ 2077760-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 6, 2024
    Expiry Date
    September 5, 2029
    Manufacturer
    Weihai Hongyu Nonwoven Fabric Products Co.,Ltd

    Certificate Lifecycle

    September 6, 2024 September 5, 2029

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    T010101 - LATEX SURGICAL GLOVES V010101 - SCALPELS WITH SAFETY SYSTEMS, SINGLE USE

    Quality Procedure Scope

    Device Group Class I Sterile

    T020401 - STANDARD SURGICAL GOWNS T020402 - REINFORCED SURGICAL GOWNS T020603 - MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR T020199 - SURGICAL DRAPES – OTHER T020499 - SURGICAL GOWNS – OTHER T030199 - COVERS, INSTRUMENTS AND EQUIPMENT – OTHER T0207 - CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) M020102 - COTTON GAUZES, FOLDED A020199 - SYRINGES, SINGLE-USE – OTHER T0399 - PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER

    Quality Procedure Scope

    System Procedure Pack

    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.