BEUDAMED
    FDA Registration Active 🇫🇷 France

    CEZANNE SAS

    Reg #: 3005847079 · FEI: 3005847079 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    8

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    Registration Details

    Registration Name
    CEZANNE SAS
    Registration Number
    3005847079
    FEI Number
    3005847079
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    280 allee Graham Bell, Parc Scientifique Georges Besse
    City
    NIMES Gard
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K222251

    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

    Products

    Device Name Product Code
    Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens PMT
    Antigen, Inflammatory Response Marker, Sepsis NTM
    Procalcitonin Assay PRI
    Prognostic Test For Development Or Progression Of Preeclampsia QWH
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Chromogranin A QXS
    Calibrator, Secondary JIT
    Fluorometer JZT

    Proprietary Names

    B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S sFlt-1 KRYPTOR B.R.A.H.M.S PlGF plus KRYPTOR PreClara Ratio (sFlt-1/PlGF) [New system name] B.R.A.H.M.S PlGF / sFlt-1 KRYPTOR test system [Old system name] B.R.A.H.M.S PlGF plus KRYPTOR LIN B.R.A.H.M.S PlGF plus KRYPTOR QC B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S sFlt-1 KRYPTOR LIN B.R.A.H.M.S sFlt-1 KRYPTOR QC B.R.A.H.M.S CgA II KRYPTOR QC B.R.A.H.M.S CgA II KRYPTOR B.R.A.H.M.S PlGF plus KRYPTOR CAL B.R.A.H.M.S CgA II KRYPTOR CAL B.R.A.H.M.S PCT sensitive KRYPTOR CAL B.R.A.H.M.S sFlt-1 KRYPTOR CAL B.R.A.H.M.S KRYPTOR BUFFER B.R.A.H.M.S KRYPTOR compact SOLUTION 3 B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S KRYPTOR compact REACT B.R.A.H.M.S KRYPTOR compact DILCUP B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S KRYPTOR compact SOLUTION 4 B.R.A.H.M.S KRYPTOR compact SOLUTION 1

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device