Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
HU-MF-000020416 · Hungary · Budapest
Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság is registered in the European database on medical devices as a manufacturer, with 90 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Abacus 380 hematology analyzer, Aquarius 3 Hematology Analyzer, Aquila Hematology Analyzer, Chemistry Analyzer, Clinilcal Chemistry analyzers.
Devices declared under this manufacturer
- 3 Hematology Scan
- Abacus 380 Hematology Analyzer
- Abacus 5 Hematology Analyzer
- Abacus Junior 30 Hematology Analyzer
- Aquila Hematology Analyzer
- Atellica DT 250 analyzer
- Atellica DT Solution 1 (S1)
- Autopak 300 Clinical Chemistry Autoanalyzer with ISE module
- Cuvette Cleaner solutions
- Diatro•Cleaner
- Diatro•Dil-5P
- FW500 Clinical Chemistry Analyzer with ISE module
Showing 12 of 90 declared devices.
Catalogue references include A1-1, A380-1, A5-1, APK300i, D5011, DATR3PA3N-AV.
European nomenclature codes declared: W0202010201, W0201010106, W0599, W0103010105, W0202010101, W0103010502.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 90 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 90 |
|---|---|
| Found in the U.S. device database | 18 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság was not found in either the U.S. or the Canadian register.