BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    STIHLER ELECTRONIC GMBH

    Reg #: 9617473 · FEI: 3001733054 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    STIHLER ELECTRONIC GMBH
    Registration Number
    9617473
    FEI Number
    3001733054
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gaussstrasse 4
    City
    Leinfelden-Echterdingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K020103

    Owner / Operator

    Firm Name
    STIHLER ELECTRONIC GMBH
    Operator Number
    9036252
    Address
    Gaussstrasse 4, --
    City
    Leinfelden-Echterdingen Baden-Wurttember
    State
    DE-NOTA
    Postal Code
    70771
    Country
    DE

    US Agent

    Business Name
    Gentherm Medical
    Contact Name
    Angie Gegner
    Address
    12011 Mosteller Road
    City
    Cincinnati
    State
    OH
    ZIP
    45241
    Country
    US
    Email
    [email protected]
    Phone
    513 3265228

    Products

    Device Name Product Code
    Accessories, Blood Circuit, Hemodialysis KOC
    Warmer, Thermal, Infusion Fluid LGZ
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    System, Thermal Regulating DWJ
    Transilluminator, Battery-Powered HJN

    Proprietary Names

    PRISMAFLO, PRISMAFLO II ASTOTHERM PLUS, ASTOTUBE, ASTOLINE M77455502 M77432002 PRISMATHERM II Prismaflo II Prismaflo IIS ASTOPAD Patient Warming System Astoflo Plus Astoflo Plus ECO Astodia

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198