BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ROTOMED AG

    Reg #: 9614469 · FEI: 3002928011 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROTOMED AG
    Registration Number
    9614469
    FEI Number
    3002928011
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Allmendstrasse 4
    City
    Bellach Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K191479

    Owner / Operator

    Firm Name
    Rotomed AG
    Operator Number
    10042961
    Address
    Allmendstrasse 4
    City
    Bellach
    State
    Solothurn
    Postal Code
    4512
    Country
    CH

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)