BEUDAMED
    FDA Registration Active 🇫🇷 France

    PreClara Ratio (sFlt-1/PlGF) [New system name]

    Reg #: 3005847079 · FEI: 3005847079 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CEZANNE SAS
    Registration Number
    3005847079
    FEI Number
    3005847079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    280 allee Graham Bell, Parc Scientifique Georges Besse
    City
    NIMES Gard
    Country
    FR

    Regulatory Submissions

    510(k) Number
    DEN220027

    Owner / Operator

    Firm Name
    B.R.A.H.M.S GmbH
    Operator Number
    10025840
    Address
    Neuendorfstrasse 25
    City
    Hennigsdorf
    State
    Brandenburg
    Postal Code
    16761
    Country
    DE
    Correspondent
    Elli Neu

    US Agent

    Business Name
    Fisher Diagnostics Inc., as part of Thermo Fisher Scientific
    Contact Name
    Colleen Watson
    Address
    8365 Valley Pike
    City
    Middletown
    State
    VA
    ZIP
    22645
    Country
    US
    Email
    [email protected]
    Phone
    224 2797203

    Products

    Device Name Product Code
    Prognostic Test For Development Or Progression Of Preeclampsia QWH

    Proprietary Names

    PreClara Ratio (sFlt-1/PlGF) [New system name] B.R.A.H.M.S sFlt-1 KRYPTOR B.R.A.H.M.S PlGF plus KRYPTOR B.R.A.H.M.S PlGF / sFlt-1 KRYPTOR test system [Old system name]

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)