BEUDAMED
    FDA Registration Active 🇫🇷 France

    SOPHY

    Reg #: 3006240422 · FEI: 3001587388 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOPHYSA
    Registration Number
    3006240422
    FEI Number
    3001587388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue Sophie Germain, Technopole TEMIS
    City
    BESANCON Doubs
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K013488

    Owner / Operator

    Firm Name
    SOPHYSA
    Operator Number
    10023919
    Address
    5 RUE GUY MOQUET
    City
    ORSAY
    State
    Essonne
    Postal Code
    91400
    Country
    FR
    Correspondent
    Philippe NEGRE

    US Agent

    Business Name
    Sophysa USA Inc.
    Contact Name
    Tim TIPKA
    Address
    503 E Summit St, Suite 5
    City
    Crown Point
    State
    IN
    ZIP
    46307
    Country
    US
    Email
    [email protected]
    Phone
    330 8014346

    Products

    Device Name Product Code
    Shunt, Central Nervous System And Components JXG

    Proprietary Names

    SOPHY

    Establishment Types

    Manufacture Medical Device