BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    HCMED INNOVATIONS CO., LTD.

    Reg #: 3016750005 · FEI: 3016750005 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    HCMED INNOVATIONS CO., LTD.
    Registration Number
    3016750005
    FEI Number
    3016750005
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F., No.166, Jiankang Rd., Zhonghe Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K250583

    Owner / Operator

    Firm Name
    HCMed Innovations Co., Ltd.
    Operator Number
    10082903
    Address
    Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    10669
    Country
    TW
    Correspondent
    Michelle Pieh

    Products

    Device Name Product Code
    Mask, Oxygen BYG
    Nebulizer (Direct Patient Interface) CAF
    Mouthpiece, Breathing BYP

    Proprietary Names

    Aerogen Go® Mask (Pediatric) Aerogen Go® Mask (Adult) AdheResp Pulmogine® Aerogen Go Vibrating Mesh Nebulizer Aerogen Go Medication Reservoir Aerogen Go Vibrating Mesh Nebulizer, Aerogen Go® Mask (Adult), Aerogen Go® Mask (Pediatric), Aerogen Go® Mouthpiece Aerogen Go AC/DC Adapter Aerogen Go® Mouthpiece

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198