BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2114114-1

    Manufacturer: Ningbo Xinwell Medical Technology Co., Ltd
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    3
    Characteristics
    1
    Revision
    3
    112
    Expires in 112 days
    Expiry: September 29, 2026

    Basic Information

    Number
    HZ 2114114-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 5, 2024
    Expiry Date
    September 29, 2026
    Revision
    3
    Manufacturer
    Ningbo Xinwell Medical Technology Co., Ltd

    Certificate Lifecycle

    November 5, 2024 September 29, 2026

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES A010201 - NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE G030499 - ERCP AND SPHINCTEROTOMY DEVICES - OTHER U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC R030101 - VENTILATION MASKS R040199 - VENTILATION FILTERS - OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE A010101 - HYPODERMIC NEEDLES

    Quality Procedure Scope

    Device Group Class IIb

    G030402 - ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND SPHINCTEROTOMY DEVICES PAPILLOTOMES / SPHINCTEROTOMES

    Quality Procedure Scope

    Device Group Class I Sterile

    A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE

    Preceding Certificates

    HZ 2114114-1 Issued
    Issued: December 27, 2023 Expires: September 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.