BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    CENEFOM CORP

    Reg #: 3010610457 · FEI: 3010610457 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    CENEFOM CORP
    Registration Number
    3010610457
    FEI Number
    3010610457
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3F, No. 50-3, Keyan Rd.
    City
    Zhunan Township Miaoli
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K082460

    Owner / Operator

    Firm Name
    Cenefom Corp.
    Operator Number
    10045592
    Address
    1F, No. 50-5, Keyan Rd.
    City
    Zhunan Township
    State
    Miaoli
    Postal Code
    350401
    Country
    TW
    Correspondent
    Tommy Hsu

    US Agent

    Business Name
    Crius Pacific Medical Inc.
    Contact Name
    Michael Zhao
    Address
    343 Minorca Way
    City
    Millbrae
    State
    CA
    ZIP
    94030
    Country
    US
    Email
    [email protected]
    Phone
    650 9425983

    Products

    Device Name Product Code
    Splint, Intranasal Septal LYA
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Sponge, Ophthalmic HOZ
    Balloon, Epistaxis EMX
    Applicator, Absorbent Tipped, Sterile KXG
    Gauze/Sponge, Internal, X-Ray Detectable GDY

    Proprietary Names

    CENEFOM Cenefom Ophthalmic sponges Disposable Sampling Swab, Disposable Sterile Sampling Swab pva sponge, internal, x-ray detectable

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)