BEUDAMED
    FDA Registration Active 🇨🇳 China

    GCMEDICA ENTERPRISE LTD.(WUXI)

    Reg #: 3018503755 · FEI: 3018503755 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    47

    Registration Details

    Registration Name
    GCMEDICA ENTERPRISE LTD.(WUXI)
    Registration Number
    3018503755
    FEI Number
    3018503755
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18 Xinjin road,Xinwu Industrial Zone,Wuxi,214000,China
    City
    WUXI Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K182819

    Owner / Operator

    Firm Name
    GCMEDICA ENTERPRISE LTD.(WUXI)
    Operator Number
    10080904
    Address
    18 Xinjin road,Xinwu Industrial Zone,Wuxi,214000,China
    City
    WUXI
    State
    Jiangsu
    Postal Code
    214000
    Country
    CN
    Correspondent
    Adam Jiang

    US Agent

    Business Name
    G&C Medical Technology Inc.
    Contact Name
    Xinlu Huang
    Address
    1775 Tysons Blvd, 5th Floor Mclean, VA 22102, USA
    City
    McLean
    State
    VA
    ZIP
    22102
    Country
    US
    Email
    [email protected]
    Phone
    703 7626336

    Products

    Device Name Product Code
    Catheters, Suction, Tracheobronchial BSY
    Sling, Arm ILI
    Syringe, Irrigating (Non Dental) KYZ
    Joint, Knee, External Brace ITQ
    Catheter And Tip, Suction JOL
    Bath, Sitz, Nonpowered KTC
    Light, Surgical, Accessories FTA
    Tube, Aspirating, Flexible, Connecting BYY
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Dispenser, Solid Medication NXB
    Bottle, Collection, Vacuum KDQ
    Infusor, Pressure, For I.V. Bags KZD
    Support, Arm IOY
    Brush, Scrub, Operating-Room GEC
    Airway, Oropharyngeal, Anesthesiology CAE
    Orthosis, Lumbo-Sacral IPY
    Set, I.V. Fluid Transfer LHI
    Cannula, Nasal, Oxygen CAT
    Urinal FNP
    Basin, Emesis FNY
    Joint, Ankle, External Brace ITW
    Cushion, Flotation KIC
    Container, Sharps MMK
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Camera, Surgical And Accessories KQM
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Accessory, Surgical Apparel LYU
    Mask, Oxygen BYG
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Container, Liquid Medication, Graduated KYW
    Stylet, Tracheal Tube BSR
    Device, Patient Transfer, Powered FRZ
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Aid, Transfer IKX
    Trap, Sterile Specimen BYZ
    Orthosis, Cervical IQK
    Snare, Surgical GAE
    Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
    Mask, Oxygen, Non-Rebreathing KGB
    Tubing, Noninvasive GAZ
    Curette, Suction, Endometrial (And Accessories) HHK
    Tips And Pads, Cane, Crutch And Walker INP
    Catheter, Ventricular, General & Plastic Surgery GBS
    Splint, Hand, And Components ILH
    Table, Cysto, Non-Electrical EYH
    Kit, Surgical Instrument, Disposable KDD

    Proprietary Names

    Bulb Irrigation Syringe Aspiration Tubing Set Orthopedic Super Sucker Set Suction Connecting Tubes Vein Cannual Vessel Cannual Sharp Container Mucosal Atomization Device Suture Retriever amnio hook Walker Ball/Equate Walker Ball

    Establishment Types

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