BEUDAMED
    FDA Registration Active 🇨🇳 China

    GAUKE (HUBEI) HEALTHCARE CO., LTD

    Reg #: 3034605486 · FEI: 3034605486 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    35
    Establishment Types
    7
    Classifications
    33

    Registration Details

    Registration Name
    GAUKE (HUBEI) HEALTHCARE CO., LTD
    Registration Number
    3034605486
    FEI Number
    3034605486
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 8, Jiangbei Highway, TuanFeng Town,
    City
    Huanggang City Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K170393

    Owner / Operator

    Firm Name
    Gauke (Hubei) Healthcare Co., Ltd
    Operator Number
    10091992
    Address
    No. 8, Jiangbei Highway, TuanFeng Town,
    City
    Huanggang City
    State
    Hubei
    Postal Code
    438000
    Country
    CN

    US Agent

    Business Name
    Registrar Corp.
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Stethoscope, Manual LDE
    Finger Cot LZB
    Pack, Hot Or Cold, Disposable IMD
    Dressing, Wound, Occlusive NAD
    Device, Finger-Sucking LQX
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Tape And Bandage, Adhesive KGX
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Mask, Oxygen, Non-Rebreathing KGB
    Tourniquet, Nonpneumatic GAX
    Mask, Scavenging KHA
    Cotton, Roll EFN
    First Aid Kit With Drug LRR
    Bandage, Cast ITG
    Forceps HTD
    Dressing, Compression MHW
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Sling, Arm ILI
    First Aid Kit Without Drug OHO
    Pad, Eye HMP
    Disinfectant, Medical Devices LRJ
    Bedding, Disposable, Medical KME
    Pad, Alcohol, Device Disinfectant LKB
    Anaerobic Box Glove JTM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Polymer Patient Examination Glove LZA
    Bandage, Liquid, Skin Protectant NEC
    Accessory, Surgical Apparel LYU
    Scissors, General, Surgical LRW
    Applicator, Absorbent Tipped, Sterile KXG
    Bandage, Elastic FQM
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Mask, Oxygen BYG

    Proprietary Names

    Stethoscope Finger cover Cold compress/pack; heat pack Transparent wound dressing; wound dressing; cheat seal splint, wire splint Gauke Brand Splint Roll ADHESIVE TAPE; ROLLER BANDAGE; STERILE ADHESIVE BANDAGE; TRIANGULAR BANDAGE Gauze sponge CPR mask CAT Tourniquet Face mask Cotton ball Cotton Zig-zag cotton roll Cotton roll First Aid Kit First aid dressing bandages BANDAGE COMPRESS; BURN DRESSING; NON-ADHERENT PAD; STERILE ABSORBENT COMPRESS; STERILE GAUZE SWABS Burn Dressing; Burn Gel; Burn Relieve Triangular bandages EYE COVERING Alcohol prep pad; Pads; povidone iodine prep pads First aid blanket Alcohol pad gloves Gauze sponges, Gauze compress, Gauze swabs, ABD pad, Trauma pad Examination glove Antiseptic towelette; Antiseptic wipes Face shield,Hand towel,shoe cover,drape Scissors cotton tips cotton applicators Conforming elastic bandages, crepe bandages Cotton tips, cotton swabs MASK, OXYGEN

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Remanufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device