NORMA Instruments Zártkörűen Működő Részvénytársaság
HU-MF-000014244 · Hungary · Budapest
NORMA Instruments Zártkörűen Működő Részvénytársaság is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Norma Autoloader, Norma Icon-3, Norma Icon-5, Norma-iClean5, Norma-iDil3.
Devices declared under this manufacturer
- H3/5-Hypoclean
- H5-Compact 250-O
- H5-Compact 400
- Hemolyzer® 3 NG automated 3-part differential hematology analyzer
- Hemolyzer® 5 NG automated 5-part differential hematology analyzer with
- Norma Autoloader demo accessory unit for automated sample vial loading
- Norma Icon-5 automated 5-part differential hematology analyzer with cl
- Norma-iClean5
- Norma-iDil3
- Norma-iHClean
- Norma-iOptiClean
- Norma-iSol3
Showing 12 of 61 declared devices.
Catalogue references include HE3413, HE5709, IC-41731, IC-51755, IC-81731, IC-81750.
European nomenclature codes declared: W0103010105, W0202010101, W0202010201, W0103010502, W0103010501, W0103010503.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 61 |
| 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 | 61 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. NORMA Instruments Zártkörűen Működő Részvénytársaság was not found in either the U.S. or the Canadian register.