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Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Active in EUDAMED

Registered as Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság (Diatron MI Zrt.) in EUDAMED

Hungaryfrom SRN EUDAMED SRN HU-MF-000020416

Devices
87
Registrations
EUDAMED

What Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag makes

The company produces in vitro diagnostic (IVD) reagents and analysers for clinical laboratories, including blood cell lysis reagents like Diatro•Lyse-5P and Diatro•Lyse-DIFF for haematological testing, as well as automated and semi-automated wash/cleaning solutions such as Diatro•Hypoclean CC. It also manufactures multiple clinical chemistry analysers, including the Pictus 400, alongside haematology analysers like the Abacus 5 and ABACUS 3CP for blood cell analysis. Additionally, the portfolio includes buffered sample diluents (e.g., Diatro•Dil-5P and Diatro•Dil-DIFF) and ion-selective electrodes for measuring electrolytes like potassium (K+), sodium (Na+), and chloride (Cl-), such as the K ELECTRODE and CL ELECTRODE modules.

The company’s devices are classified under EU regulations as Class A, Class I, and Class II, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Hungary and adheres to relevant regulatory frameworks for in vitro diagnostics in both European and U.S. markets.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
HU-MF-000020416
DUNS number
427395277
EU VAT number
HU13863326
EUDAMED status
Active
EUDAMED registered name
Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
EUDAMED abbreviated name
Diatron MI Zrt.
Registered address
39, Táblás utca, H-1097, Budapest, Hungary
Phone
+36306046948
PRRC contact
András Vámos(public in EUDAMED)