BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Gynocular colposcope

    Reg #: 3014982233 · FEI: 3014982233 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GYNIUS PLUS AB
    Registration Number
    3014982233
    FEI Number
    3014982233
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Jarnbrotts Prastvag 2
    City
    Gothenburg Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K132423

    Owner / Operator

    Firm Name
    Gynius Plus AB
    Operator Number
    10058536
    Address
    Jarnbrotts Prastvag 2
    City
    Gothenburg
    State
    Vastra Gotaland
    Postal Code
    42147
    Country
    SE
    Correspondent
    Huaqing Li

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    202 8411075

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    Gynocular colposcope

    Establishment Types

    Manufacture Medical Device