BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Diatron MI Plc

    Reg #: 3009297077 · FEI: 3009297077 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    27
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    Diatron MI Plc
    Registration Number
    3009297077
    FEI Number
    3009297077
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tablas str. 39
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K112755

    Owner / Operator

    Firm Name
    Diatron MI Plc
    Operator Number
    10040448
    Address
    Tablas u. 39
    City
    Budapest
    State
    HU-BU
    Postal Code
    H-1097
    Country
    HU
    Correspondent
    Andras Vamos

    US Agent

    Business Name
    Diatron US Inc.
    Contact Name
    Frank Matuszak
    Address
    12601 NW 115th Avenue Suite A 113
    City
    Medley
    State
    FL
    ZIP
    33178
    Country
    US
    Email
    [email protected]
    Phone
    833 2287931

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Counter, Differential Cell GKZ
    General Purpose Reagent PPM
    Products, Red-Cell Lysing Products GGK
    Detergent JCB
    Diluent, Blood Cell GIF
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    Pictus 700 Clinical Chemistry Analyzer P500, Diatron Pictus 500 APK300, Autopak 300 Clinical Chemistry Autoanalyzer P780 Clinical Chemistry Analyzer Abacus 5 Hematology Analyzer Abacus 5 Autoloader Trigger Solution 1 KleeYa Trigger Solutions Pack Trigger Solution 2 Diatro Diff-5P Diatro Lyse-DIFF Diatro Lyse-5P Diatro Cleaner Additive for wash solution Cuvette Cleaner Solutions Solution1 Hypochlorite Cleaning Solution Solution2 Rinsing Solution Cuvette Cleaner Solution3 Additive for Wash Solution 5x TBS Wash Buffer Diatro Hypoclean Cleaning Solution Cleaning kit Diatro Hypoclean CC Diatro Dil 5P Diatro Dil DIFF Abacus 3CP Hematology Analyzer

    Establishment Types

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