BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    TRINITY BIOTECH, PLC

    Reg #: 9681576 · FEI: 3002546385 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    TRINITY BIOTECH, PLC
    Registration Number
    9681576
    FEI Number
    3002546385
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA BUSINESS PARK
    City
    BRAY Wicklow
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K854245

    Owner / Operator

    Firm Name
    TRINITY BIOTECH, PLC
    Operator Number
    9025161
    Address
    2823 Girts Rd
    City
    Jamestown
    State
    NY
    Postal Code
    14701
    Country
    US

    US Agent

    Business Name
    Trinity Biotech
    Contact Name
    Kaitlyn Eastman
    Address
    4231 E. 75th Terrace
    City
    Kansas City
    State
    MO
    ZIP
    64132
    Country
    US
    Email
    [email protected]
    Phone
    716 4837423

    Products

    Device Name Product Code
    Culture Media, Non-Propagating Transport JSM
    Radioassay, Angiotensin Converting Enzyme KQN
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Platelet Antibody MYP
    Solution, Stabilized Enzyme KSK
    Radioimmunoassay, Cholyglycine, Bile Acids KWW
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening JBF
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot JBG
    System, Test, Oxalate LPW
    Calibrator, Secondary JIT
    Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative JBL
    Urinalysis Controls (Assayed And Unassayed) JJW

    Proprietary Names

    Bartels Flex Trans Medium Trinity Biotech IMMUCOR GAMMA Human Platelet Concebtrate IMMUCOR GAMMA Freeze Dried Papain IMMUCOR GAMMA W.A.R.M. (Warm Autoantibody Removal Medium)

    Establishment Types

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