BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    MEDICEL AG

    Reg #: 9681862 · FEI: 1000581837 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    55
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MEDICEL AG
    Registration Number
    9681862
    FEI Number
    1000581837
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dornierstrasse 11
    City
    Altenrhein Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K070669

    Owner / Operator

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

    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
    Lens, Guide, Intraocular KYB
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Cannula, Ophthalmic HMX

    Proprietary Names

    Viscoject 2.2 Viscoject 1.8 211026 EyeGility Inserter for Preloaded enVista IOLs (2) 211027 EyeGility Inserter for Preloaded enVista IOLs (2.4) VIS100 SimplifEYE for enVista Preloaded SimplifEYE inserter for Akreos preloaded ACCUJECT Injector Set 2.1-1P ACCUJECT Injector Set 2.2-1P SMS120 SMS125 SMS125P SMS155P SMS165P SBS110A SMS165 SMS115 SMS170P SMS130 SMS160P SMS135P SMS175P SMS135 SMS370P SMS430 SBS105 SMS410 SMS355P SMS335 SMS325P SMS390S SBS123A SBS310A MCS4523P SBS320A MBSCR23 MCS4521ST MCS4521P MBSCR21 MCS6520T 3032-23 MCS4520P I/A Bimanual Handpiece Set Sophi - 21G I/A Coaxial Handpiece Set Sophi - 21G/45° I/A Coaxial Handpiece Set Sophi - 20G/45° I/A Coaxial Handpiece Set Sophi - 23G/45° I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip BIT23A I/A Bimanual Handpiece Set Sophi -21G/Aeroplane I/A Coaxial Handpiece Set Sophi - 20G/65° I/A Bimanual Handpiece Set Sophi - 23G BIT21A SimplifEYE inserter for enVista Preloaded BLIS-X1 Medicel ACCUJECT REFRA Injector

    Establishment Types

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