BEUDAMED
    FDA Registration Active 🇧🇬 Bulgaria

    SCHOELLY-OPTIX OOD

    Reg #: 3014644276 · FEI: 3006149253 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SCHOELLY-OPTIX OOD
    Registration Number
    3014644276
    FEI Number
    3006149253
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Krastyo Geshanov 30
    City
    Panagyurishte Pazardzhik
    Country
    BG

    Regulatory Submissions

    510(k) Number
    K081137

    Owner / Operator

    Firm Name
    SCHOELLY FIBEROPTIC, GMBH
    Operator Number
    9004385
    Address
    ROBERT-BOSCH-STR. 1-3, --
    City
    DENZLINGEN
    State
    DE-NOTA
    Postal Code
    79211
    Country
    DE
    Correspondent
    GERHARD - HERBSTRITT

    US Agent

    Business Name
    SCHOELLY USA Inc.
    Contact Name
    James Bonneville
    Address
    360 Church St., Suite 130
    City
    Northborough
    State
    MA
    ZIP
    01532
    Country
    US
    Email
    [email protected]
    Phone
    508 9268855

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)