BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SUTTER MEDIZINTECHNIK GMBH

    Reg #: 8044091 · FEI: 3004857377 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    5
    Classifications
    5

    Registration Details

    Registration Name
    SUTTER MEDIZINTECHNIK GMBH
    Registration Number
    8044091
    FEI Number
    3004857377
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Alfred-Walz-Strasse 22
    City
    Emmendingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K251813

    Owner / Operator

    Firm Name
    Sutter Medizintechnik GmbH
    Operator Number
    9005453
    Address
    Alfred-Walz-Strasse 22
    City
    Emmendingen
    State
    Baden-Wurttemberg
    Postal Code
    79312
    Country
    DE

    US Agent

    Business Name
    BUSINESS SUPPORT INTERNATIONAL
    Contact Name
    Angelika Scherp
    Address
    1350 Avenue Of The Americas FL 2nd
    City
    New York
    State
    NY
    ZIP
    10019
    Country
    US
    Email
    [email protected]
    Phone
    212 3318358

    Products

    Device Name Product Code
    Arthroscope HRX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tray, Surgical, Instrument FSM
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Lavage, Jet FQH

    Proprietary Names

    Bipolar cable SUTTER Electrosurgical Cables

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device