BEUDAMED
    FDA Registration Active 🇨🇳 China

    NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.

    Reg #: 3017178358 · FEI: 3017178358 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3017178358
    FEI Number
    3017178358
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.188 Binjiang Road,Cixi High-tech Industrial Development Zone, Cixi City, Zhejiang, 315301, P.R.China
    City
    Cixi Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232969

    Owner / Operator

    Firm Name
    Ningbo Xinwell Medical Technology Co., Ltd.
    Operator Number
    10075092
    Address
    No.188 Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi City, 315301, Zhejiang,P.R.China
    City
    Cixi
    State
    Zhejiang
    Postal Code
    315301
    Country
    CN
    Correspondent
    Lei Xi

    Products

    Device Name Product Code
    Blood Pressure Cuff DXQ
    Laryngoscope, Rigid CCW
    Hemostatic Metal Clip For The Gi Tract PKL
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Mask, Gas, Anesthetic BSJ
    Point, Abrasive EHL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Forceps, Biopsy, Non-Electric FCL
    Catheters, Suction, Tracheobronchial BSY
    Bottle, Collection, Vacuum KDQ

    Proprietary Names

    blood pressure cuff Video laryngoscope Hemostatic Metal Clip For The Gi Tract-Disposable Hemostatic Clips Patient monitoring Cables for ECG, EKG, SpO2 and Blood Pressure Monitors Circuit, breathing (w connector, adaptor, y piece) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) MASK, GAS, ANESTHETIC All Ceramic Polishers FlexiPoints MASS SPECTROMETRY MONITORING LINE CONONECTORS Disposable Injection Needles Disposable biopsy forceps CATHETER,SUCTION Disposable Water Seal Chest Drainage System Disposable Dry Seal Chest Drainage System K120364

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device