BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    STRATEC SE

    Reg #: 8043379 · FEI: 3003413192 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    STRATEC SE
    Registration Number
    8043379
    FEI Number
    3003413192
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GEWERBESTRASSE 37
    City
    BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    STRATEC SE
    Operator Number
    9001219
    Address
    GEWERBESTRASSE 37, --
    City
    BIRKENFELD, GRAEFENHAUSEN, BW
    State
    Baden-Wurttemberg
    Postal Code
    75217
    Country
    DE
    Correspondent
    VOLKER - SCHWAAB

    US Agent

    Business Name
    Diatron US Inc.
    Contact Name
    Frank Matuszak
    Address
    12601 NW 115th Avenue Suite A 113
    City
    Medley
    State
    FL
    ZIP
    33178
    Country
    US
    Email
    [email protected]
    Phone
    833 2287931

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ
    Instrumentation For Clinical Multiplex Test Systems NSU
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis PER
    Real Time Nucleic Acid Amplification System OOI
    Flow Cytometric Reagents And Accessories. OYE
    Clinical Sample Concentrator JJH
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Station, Pipetting And Diluting, For Clinical Use JQW

    Proprietary Names

    InviGenius® InviGenius® PLUS GEMINI Compact Microplate Processor GEMINI Combo KleeYa instrument

    Establishment Types

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