BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TearLab Osmolarity System

    Reg #: 3007137761 · FEI: 3007137761 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Trukera Medical
    Registration Number
    3007137761
    FEI Number
    3007137761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    42309 Winchester Rd, Suite I
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083184

    Owner / Operator

    Firm Name
    Trukera Medical
    Operator Number
    10026657
    Address
    42309 Winchester Rd, Suite I
    City
    Temecula
    State
    CA
    Postal Code
    92590
    Country
    US

    Products

    Device Name Product Code
    Osmolality Of Tears OND
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    TearLab Osmolarity System ScoutPro Osmolarity System

    Establishment Types

    Manufacture Medical Device