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    FDA Registration Active 🇨🇳 China

    ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.

    Reg #: 3004134948 · FEI: 3004134948 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    19
    Establishment Types
    3
    Classifications
    13

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    Registration Details

    Registration Name
    ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.
    Registration Number
    3004134948
    FEI Number
    3004134948
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18 Xinlian Street, Xinshi Town, Deqing County
    City
    Huzhou City Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K101565

    Owner / Operator

    Firm Name
    ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.
    Operator Number
    9058200
    Address
    18 Xinlian Street, Xinshi Town, Deqing County
    City
    Huzhou City
    State
    Zhejiang
    Postal Code
    313201
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Accessory, Surgical Apparel LYU
    Mask, Oxygen, Low Concentration, Venturi BYF
    Vinyl Patient Examination Glove LYZ
    Mask, Oxygen BYG
    Mask, Oxygen, Non-Rebreathing KGB
    Tracheobronchial Suction Catheter Kit OFR
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Bag, Reservoir BTC
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Catheters, Suction, Tracheobronchial BSY
    Catheter, Irrigation GBX
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    NON SURGICAL MEDICAL MASK NON SURGICAL DUST MASK NON SURGICAL PARTICLE RESPIRATOR EYE SHIELD PROTECTION SHIELD FACE SHIELD NON SURGICAL FACE MASK Venturi Mask with 6 Diluter Jets POWDER -FREE PATIENT EXAMINATION GLOVES OXYGEN MASK(WITH OPTIONAL OXYGEN TUBE, NEBULIZER,AIR BAG, CHAMBER OR VALVES) Non-Rebreathing Mask with 2M Tube Suction Catheter Kit NEBULIZER/NEBULIZER KIT/NEBULIZERS MULTIPLE (AEROSOL DRAINAGE SYSTEM) Humidifier CORRUGATED TUBING SUCTION CATHETER, COILED Infiltration Tubing MULTIPLE (NASAL OXYGEN CANNULA, OXYGEN CANNULA)

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)