BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    KELABIT S.R.O.

    Reg #: 3010640396 · FEI: 3010640396 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KELABIT S.R.O.
    Registration Number
    3010640396
    FEI Number
    3010640396
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Na Mlynici 13
    City
    Ostrava Moravskoslezsky Kraj
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K091339
    PMA Number
    N17676

    Owner / Operator

    Firm Name
    Kelabit s.r.o.
    Operator Number
    10051198
    Address
    Na Mlynici 13
    City
    Privoz
    State
    Ostrava-Mesto
    Postal Code
    702 00
    Country
    CZ
    Correspondent
    Tomas Sotak

    Products

    Device Name Product Code
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL
    Lenses, Soft Contact, Extended Wear LPM

    Proprietary Names

    MY DAY DW 90 PACK COOPERVISION Total30 Precision 1 BALAFILCON A - Contact Lens AVAIRA VITALITY ACUVUE VITA 6 PACK DW Clarity 1 Day for Atigmatism ULTRA PureVision 2HD AIR OPTIX plus HydraGlyde Acuvue Oasys MAX 1 Day BIOFINITY FreshLook ColorBlends FreshLook Colors FreshLook Dimensions

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device