BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ENCHANT TEK CO. LTD.

    Reg #: 3012329712 · FEI: 3012329712 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    ENCHANT TEK CO. LTD.
    Registration Number
    3012329712
    FEI Number
    3012329712
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 210 Xiangzhong Rd.
    City
    Dongshan Township, Yilan County Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K233855

    Owner / Operator

    Firm Name
    Enchant Tek Co. Ltd.
    Operator Number
    10051441
    Address
    No. 210 Xiangzhong Rd.
    City
    Dongshan Township, Yilan County
    State
    TW-NOTA
    Postal Code
    26950
    Country
    TW
    Correspondent
    Mu Hua Huang

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    MATT DRYDEN
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Spirometer, Therapeutic (Incentive) BWF
    Floss, Dental JES
    Toothbrush, Manual EFW
    Mouthpiece, Breathing BYP
    Filter, Bacterial, Breathing-Circuit CAH
    Nebulizer (Direct Patient Interface) CAF
    Tip, Rubber, Oral Hygiene JEW

    Proprietary Names

    AllPEP 3M Dental Floss Pick 3M Fine Slide Flosser 3M ESPE Floss and Toss 3M Toothbrush Mouthpiece Allfow Pulmonary Function Filter AllNEB soft dental picks

    Establishment Types

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