BEUDAMED
    FDA Registration Active 🇨🇳 China

    ELITE MEDTEK(JIANGSU) CO., LTD

    Reg #: 3012964172 · FEI: 3012964172 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    ELITE MEDTEK(JIANGSU) CO., LTD
    Registration Number
    3012964172
    FEI Number
    3012964172
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 5, Tianning Zhizao Park, No. 5 Beitanghe East Road, Tianning District
    City
    Changzhou City Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    Elite Medtek(Jiangsu) Co., Ltd
    Operator Number
    10056257
    Address
    Building 5, Tianning Zhizao Park, No. 5 Beitanghe East Road, Tianning District
    City
    Changzhou City
    State
    Jiangsu
    Postal Code
    213003
    Country
    CN
    Correspondent
    Ashly Lu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Lavage, Jet FQH
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Syringe, Balloon Inflation, Exempt PTM
    Angiography/Angioplasty Kit OEQ
    Accessory, Surgical Apparel LYU
    Instrument, Ent Manual Surgical LRC
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Bottle, Collection, Vacuum KDQ
    Tourniquet, Nonpneumatic GAX

    Proprietary Names

    Disposable Inflation Device Maniflods, stopcock, adaptor Inflation Device, Model EM-lD-D40 Inflation Device.Model EM-lD-M40 Inflation Device, Model EM-lD-D30S Inflation Device, Model EM-lD-M5 Inflation Device, Model EM-lD-D30 Inflation Device, Model EM-lD-M30S Inflation Device, Model EM-lD-M30 Inflation Device, Model EM-lD-D40S Inflation Device, Model EM-lD-M40S Inflation Device, Model EM-lD-D15S Inflation Device, Model EM-lD-D5S Inflation Device, Model EM-lD-M15 Inflation Device, Model EM-lD-D5 Disposable Inflation Device, BID-15-60-1 Inflation Device,Model EM-lD-M15S Inflation Device, Model EM-lD-M5S Inflation Device, Model EM-lD-D15 Inflation kit face shield inflation device E 01 3591S EM-ID-M14S E 01 3591 Medical Isolation Eye Mask ProTrap LumaTM In-Line Polyp Trap ProTrap LumaTM Polyp Trap Specimen Tray Radial artery tourniquet

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device