BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Oneness Biotech Co., Ltd.

    Reg #: 3015077448 · FEI: 3015077448 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Oneness Biotech Co., Ltd.
    Registration Number
    3015077448
    FEI Number
    3015077448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.8, Tangchang Rd., Nanchou Township
    City
    Pingtung County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K232655

    Owner / Operator

    Firm Name
    Oneness Biotech Co., Ltd
    Operator Number
    10087222
    Address
    35F, No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    100
    Country
    TW
    Correspondent
    Angel Hsieh

    US Agent

    Business Name
    StemCyte Inc.
    Contact Name
    Lungkuo Tai
    Address
    13800 Live Oak Avenue, Baldwin Park
    City
    Baldwin Park
    State
    CA
    ZIP
    91706
    Country
    US
    Email
    [email protected]
    Phone
    626 6462457

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device