ELCON Medical Instruments GmbH
DE-MF-000005908 · Germany · Tuttlingen
ELCON Medical Instruments GmbH is registered in the European database on medical devices as a manufacturer, with 11 268 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 268 |
|---|
Among these devices, 11 268 are declared reusable.
Catalogue references include 142-611-03, 262-117, 344-224-60CC, 410-331-08, 410-365, 440-210.
European nomenclature codes declared: L031308, S010499, L091307, L03140199, L031306, L1004.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELCON MEDICAL INSTRUMENTS GMBH (DE) · FDA 8043816 |
| Devices in EUDAMED | 11 268 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 11 268 |
|---|---|
| Found in the U.S. device database | 1 |
| 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. ELCON Medical Instruments GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1068800008 | supplemented | 2029-10-16 |