BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Panion & BF Biotech Inc. Xizhi Second Factory

    Reg #: 3013296716 · FEI: 3013296716 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    Panion & BF Biotech Inc. Xizhi Second Factory
    Registration Number
    3013296716
    FEI Number
    3013296716
    Status
    Active
    Expiry Year
    2026
    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

    Products

    Device Name Product Code
    Antigens, Cf (Including Cf Control), Poliovirus 1-3 GOH
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Antigens, All Groups, Streptococcus Spp. GTY
    Helicobacter Pylori LYR

    Proprietary Names

    Vstrip QwikID

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device