BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    BIOMARIN INTERNATIONAL LIMITED

    Reg #: 3010085632 · FEI: 3010085632 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    BIOMARIN INTERNATIONAL LIMITED
    Registration Number
    3010085632
    FEI Number
    3010085632
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Shanbally
    City
    Ringaskiddy Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K133635

    Owner / Operator

    Firm Name
    BioMarin Pharmaceutical
    Operator Number
    10054923
    Address
    105 Digital Drive
    City
    Novato
    State
    CA
    Postal Code
    94949
    Country
    US

    US Agent

    Business Name
    BioMarin Pharmaceuticals Inc
    Contact Name
    Jocelyn Oriondo
    Address
    105 Digital Drive
    City
    Novato
    State
    CA
    ZIP
    94949
    Country
    US
    Email
    [email protected]
    Phone
    415 5063102

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG

    Proprietary Names

    Easypoint Vanishpoint Brinuera Administration Kit

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198