LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
HU-MF-000002846 · Hungary · Debrecen
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 32 |
|---|
Most frequent device types declared: EC-12H System, EC-12R/S, EC-12RM, EC-12S V6, EC-2H Holter Recorder.
Among these devices, 32 are declared active, 32 with a measuring function.
Devices declared under this manufacturer
- EC-12H Recorder
- EC-12H/ABP V6 Recorder
- EC-12R/S V6
- EC-12RM
- EC-12RM V6
- EC-12S V6
- EC-2H Recorder
- EC-2H System
- EC-3H
- EC-3H System
- EC-3H/ABP V6 Recorder
- EC-3H/ABP V6 System
Showing 12 of 32 declared devices.
Catalogue references include EC-12H Recorder, EC-12H/ABP V6 Recorder, EC-12RM V6, EC-12S V6, EC-2H System, EC-3H System.
European nomenclature codes declared: Z12050403, Z12050301, Z12050402, Z12050404.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 32 |
| 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 | 26 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 15.4 % |
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. LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság. was not found in either the U.S. or the Canadian register.