BEUDAMED
    FDA Registration Active 🇫🇷 France

    FIRALIS S.A.

    Reg #: 3009523773 · FEI: 3009523773 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FIRALIS S.A.
    Registration Number
    3009523773
    FEI Number
    3009523773
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    35, rue du Fort
    City
    Huningue Haut-Rhin
    Country
    FR

    Regulatory Submissions

    510(k) Number
    DEN240032

    Owner / Operator

    Firm Name
    FIRALIS S.A.
    Operator Number
    10093823
    Address
    35, rue du Fort
    City
    Huningue
    State
    Haut-Rhin
    Postal Code
    68330
    Country
    FR
    Correspondent
    Hueseyin Firat

    US Agent

    Business Name
    FMP Inc.
    Contact Name
    Sidzigui Christelle OUEDRAOGO
    Address
    1 Broadway
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    857 3397478

    Products

    Device Name Product Code
    Neurologic Disease Risk Assessment Molecular Test SFC

    Proprietary Names

    APO-Easy® genotyping kit

    Establishment Types

    Manufacture Medical Device