EMS Handels Gesellschaft m.b.H.
AT-MF-000002599 · Austria · Korneuburg
EMS Handels Gesellschaft m.b.H. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: Sienna, Sienna Ultimate, Surpass, Surpass LT, Unique+.
Among these devices, 7 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Angelie EIS
- EMS Neurostimulator
- Sienna
- Sienna Ultimate
- Surpass
- Surpass LT
- Unique+
Catalogue references include ANG/EIS, EMS/NS, SE/EEG, SP/EMG/EP, SPLT/EMG/EP, SU/EEG.
European nomenclature codes declared: N010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EMS HANDELS GESELLSCHAFT M.B.H. (AT) · FDA 3007701713 |
| Devices in EUDAMED | 7 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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: United States only. EMS Handels Gesellschaft m.b.H. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025-MDR/QS-055 | issued | 2029-06-19 |
2024-MDR/QS-030 | issued | 2029-06-19 |