BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SCHOELLY FIBEROPTIC, GMBH

    Reg #: 8043903 · FEI: 3002808088 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    SCHOELLY FIBEROPTIC, GMBH
    Registration Number
    8043903
    FEI Number
    3002808088
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROBERT-BOSCH-STR. 1-3
    City
    DENZLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K133682

    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
    Arthroscope HRX
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Laparoscope, Gynecologic (And Accessories) HET
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Source, Carrier, Fiberoptic Light EQH
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Laryngoscope, Rigid CCW
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Hysteroscope (And Accessories) HIH
    Confocal Optical Imaging OWN
    Light Source, Fiberoptic, Routine FCW
    Kit, Nephroscope FGA
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Obturator, For Endoscope FEC
    Camera, Television, Endoscopic, Without Audio FWF
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    System, X-Ray, Angiographic IZI
    Led Light Source NTN

    Proprietary Names

    Arthroscopes Uretero-Renoscope Sealing caps Three slot membrane Light guides Hysteroscopes Cystoscopes Laparoscopes Endoscopic Camera Control Unit NIR FI Light Source Endoscopic Camera Heads 2D NIR FI Laparoscopes LED Light Sources Sinuscopes

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)