BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    P200TE

    Reg #: 9617167 · FEI: 3003060634 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OPTOS PLC
    Registration Number
    9617167
    FEI Number
    3003060634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    QUEENSFERRY HOUSE, CARNEGIE CAMPUS, ENTERPRISE WAY
    City
    DUNFERMLINE, FIFE
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K173707

    Owner / Operator

    Firm Name
    OPTOS PLC
    Operator Number
    9035556
    Address
    QUEENSFERRY HOUSE, CARNEGIE, BUSINESS CAMPUS
    City
    DUNFERMLINE, FIFE
    State
    GB-NOTA
    Postal Code
    KY11 8GR
    Country
    GB
    Correspondent
    Alan K Leitch

    Products

    Device Name Product Code
    Tomography, Optical Coherence OBO
    Ophthalmoscope, Laser, Scanning MYC

    Proprietary Names

    P200TE

    Establishment Types

    Manufacture Medical Device