Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Active in EUDAMEDHungaryfrom 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.
Catalogue
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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
- Website
- www.diatron.com
- [email protected]
- Phone
- +36306046948
- PRRC contact
- András Vámos