BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Multichem A1c 04V0610

    Reg #: 3008156187 · FEI: 3008156187 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TECHNO-PATH MANUFACTURING LTD.
    Registration Number
    3008156187
    FEI Number
    3008156187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fort Henry Business Park
    City
    Ballina Tipperary
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K162514

    Owner / Operator

    Firm Name
    Techno-path Manufacturing Ltd.
    Operator Number
    10030933
    Address
    Fort Henry Business Park
    City
    Ballina
    State
    Tipperary
    Postal Code
    V94FF1P
    Country
    IE

    US Agent

    Business Name
    LGC Clinical Diagnostics, INC.
    Contact Name
    Wais Osmani
    Address
    37 Birch St
    City
    Milford
    State
    MA
    ZIP
    01757
    Country
    US
    Email
    [email protected]
    Phone
    774 5735689

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Multichem A1c 04V0610 Multichem A1c HB000A, HB001A, HB002A, HB000M

    Establishment Types

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