BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

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    Reg #: 3013296716 · FEI: 3013296716 · Expires 2025
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    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Panion & BF Biotech Inc. Xizhi Second Factory
    Registration Number
    3013296716
    FEI Number
    3013296716
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist.,
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K183573

    Owner / Operator

    Firm Name
    Panion & BF Biotech Inc
    Operator Number
    10060384
    Address
    8F, No. 308-6, 308-8, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City, Taiwan
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    221
    Country
    TW
    Correspondent
    Huang Chun-Hao

    US Agent

    Business Name
    Arbelos Genomics Inc.
    Contact Name
    Daniel Chen
    Address
    13768 Roswell Ave. Suite 121, Chino, CA
    City
    Chino
    State
    CA
    ZIP
    91710
    Country
    US
    Email
    [email protected]
    Phone
    626 4638162

    Products

    Device Name Product Code
    Helicobacter Pylori LYR

    Proprietary Names

    Vstrip QwikID

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device