BEUDAMED
    FDA Registration Active 🇫🇷 France

    CELL DYN EMERALD 22 SYSTEM

    Reg #: 3006946274 · FEI: 3006946274 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIT Group France
    Registration Number
    3006946274
    FEI Number
    3006946274
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parc Euromedecine II Rue de la Valsiere, Cedex 5
    City
    Montpellier Herault
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K110381

    Owner / Operator

    Firm Name
    BIT Group France
    Operator Number
    10024699
    Address
    Parc Euromedecine II
    City
    Montpellier Cedex 5
    State
    Occitanie
    Postal Code
    FR-34099
    Country
    FR

    US Agent

    Business Name
    Keystone Regulatory Services, LLC
    Contact Name
    WILLIAM MCLAIN
    Address
    342 E. Main Street, Suite 207 Leola
    City
    Bareville
    State
    PA
    ZIP
    17540
    Country
    US
    Email
    [email protected]
    Phone
    717 6569656

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ

    Proprietary Names

    CELL DYN EMERALD 22 SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)