BEUDAMED
    FDA Registration Active 🇫🇷 France

    SOPHYSA

    Reg #: 3001587388 · FEI: 3001587388 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SOPHYSA
    Registration Number
    3001587388
    FEI Number
    3001587388
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    05 RUE GUY MOQUET
    City
    ORSAY, CEDEX Essonne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K162108

    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
    Paul GORDON
    Address
    503 E Summit St Ste 5
    City
    Crown Point
    State
    IN
    ZIP
    46307
    Country
    US
    Email
    [email protected]
    Phone
    219 6637711

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM
    Shunt, Central Nervous System And Components JXG
    Instrument, Shunt System Implantation GYK
    Lumbar Drainage Catheter Kit PVO

    Proprietary Names

    Pressio 2 ICP monitoring system SOPHY PRESSIO POLARIS Adjustable Pressure Valve System POLARIS Adjustable Pressure Valve SOPHYSA SHUNT SOPHYSA ACCESSORIES POLARIS Valves electronic Reading Instrument Siphon X Gravitational Anti-siphon Sophy® Mini Monopressure Valve External Drainage catheters

    Establishment Types

    Manufacture Medical Device