Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Active in EUDAMEDHungaryfrom SRN EUDAMED SRN HU-MF-000020416
- Devices
- 87
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
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
Search and filter all 87 devicesShowing 1-50 of 87
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
Frequently asked questions
How many devices does Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag have in the registry?
The registry currently lists 87 devices for Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag's devices?
Among its 50 most recently registered devices, Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag has devices listed in EUDAMED (39 devices) and FDA GUDID (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag's devices are Class I, Class II, IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag in the registry?
The most recently registered devices listed for Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag include Diacon 5 Hematology Control NORMAL Level, Diacon 3 Hematology Control Set (2L-2N-2H), Diacon 5 Hematology Control HIGH Level and Diacon 3 Hematology Control Normal.