BEUDAMED
    FDA Registration Active 🇮🇳 India

    AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYZER, MODEL ERBA EM 200

    Reg #: 3011497847 · FEI: 3011497847 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    TRANSASIA BIO-MEDICALS LIMITED
    Registration Number
    3011497847
    FEI Number
    3011497847
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SDF-VI, Unit 161/162, SEEPZ, Andheri East
    City
    Mumbai Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K130915

    Owner / Operator

    Firm Name
    ERBA LACHEMA s.r.o.
    Operator Number
    10047881
    Address
    2219/1d,
    City
    Karásek
    State
    Mesto Brno
    Postal Code
    62100
    Country
    CZ
    Correspondent
    Manish Airan

    US Agent

    Business Name
    Erba
    Contact Name
    Ignacio Toomey
    Address
    4595 49th St
    City
    San Diego
    State
    CA
    ZIP
    92115
    Country
    US
    Email
    [email protected]
    Phone
    619 5874264

    Products

    Device Name Product Code
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hexokinase, Glucose CFR
    Electrode, Ion-Specific, Chloride CGZ

    Proprietary Names

    AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYZER, MODEL ERBA EM 200 AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYSER - ERBA EM 180; AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYSER - ERBA XL 1000; AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYSER, MODEL - ERBA XL 200; AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYSER - ERBA EM 360; AUTOMATED RANDOM ACCESS CLINICAL CHEMISTRY ANALYSER - ERBA XL 640;

    Establishment Types

    Manufacture Medical Device