BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    A1AT Genotyping Test

    Reg #: 3006413195 · FEI: 3006413195 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PROGENIKA BIOPHARMA S.A.
    Registration Number
    3006413195
    FEI Number
    3006413195
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia
    City
    Derio Vizcaya
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K211115

    Owner / Operator

    Firm Name
    Progenika Biopharma S.A.
    Operator Number
    10056259
    Address
    Ibaizabal bidea, Edificio 504, Parque Tecnologico de Bizkaia
    City
    Derio
    State
    Vizcaya
    Postal Code
    48160
    Country
    ES

    US Agent

    Business Name
    GRIFOLS
    Contact Name
    Alisha McReynolds
    Address
    4560 Horton St.
    City
    Emeryville
    State
    CA
    ZIP
    94608
    Country
    US
    Email
    [email protected]
    Phone
    510 9235046

    Products

    Device Name Product Code
    Serpina1 Variant Detection System PZH

    Proprietary Names

    A1AT Genotyping Test

    Establishment Types

    Manufacture Medical Device