BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SimplifEYE inserter for enVista Preloaded

    Reg #: 9681862 · FEI: 1000581837 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDICEL AG
    Registration Number
    9681862
    FEI Number
    1000581837
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dornierstrasse 11
    City
    Altenrhein Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K192005

    Owner / Operator

    Firm Name
    MEDICEL AG
    Operator Number
    9027853
    Address
    Dornierstrasse 11, --
    City
    Altenrhein
    State
    Sankt Gallen
    Postal Code
    9423
    Country
    CH
    Correspondent
    Tobias - Maier

    US Agent

    Business Name
    Volk Optical Inc.
    Contact Name
    Peter Chen
    Address
    7893 Enterprise Dr.
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 9426161

    Products

    Device Name Product Code
    Folders And Injectors, Intraocular Lens (Iol) MSS

    Proprietary Names

    SimplifEYE inserter for enVista Preloaded

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)