BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fainteer Limited

    Reg #: 3031506335 · FEI: 3031506335 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    Fainteer Limited
    Registration Number
    3031506335
    FEI Number
    3031506335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5306 S Bannock St Ste 207
    City
    Littleton
    State
    CO
    ZIP
    80120
    Country
    US

    Regulatory Submissions

    510(k) Number
    K771105

    Owner / Operator

    Firm Name
    Fainteer Limited
    Operator Number
    10090514
    Address
    5306 S BANNOCK ST STE 207
    City
    Littleton
    State
    CO
    Postal Code
    80120
    Country
    US
    Correspondent
    Xingwang Zhang Zhang

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Spacer, Direct Patient Interface NVO
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Spirometer, Therapeutic (Incentive) BWF
    Pump, Nebulizer, Electrically Powered JPW

    Proprietary Names

    Nebulizer; Portable Nebulizer; Ultrasonic Mesh Nebulizer for Breathing Problems; Model: 503, Part: #17068 Auglam Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer(Model: NO. M-175) Portable Nebulizer, Ultrasonic Nebulizer (OTC use) Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer, Nebulizer Machine for Adults &Kids Use 77 Ultrasonic Nebulizer Easimist Ultrasonic Nebulizer Ultrasonic Nebulizer - Portable Nebulizer, Nebulizers, Rechargeable Nebulizer Machine for Adults and Kids Expiratory Breathing Exerciser

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Device in the United States for Export Only