BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    STRATEC SE

    Reg #: 8043379 · FEI: 3003413192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRATEC SE
    Registration Number
    8043379
    FEI Number
    3003413192
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GEWERBESTRASSE 37
    City
    BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201814

    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
    Flow Cytometric Reagents And Accessories. OYE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)