ewimed GmbH
DE-MF-000006409 · Germany · Hechingen-Boll
ewimed GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: connection lock.
Among these devices, 1 are declared sterile, 1 implantable.
Devices declared under this manufacturer
- drainova clickFix®
- drainova® Katheter
- drainova® cone adapter
- drainova® tunneler
Catalogue references include 1166, 6015, 6051, P1100, P1100S.
European nomenclature codes declared: A060102, A060199, A060204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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. ewimed GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 094663 0010 | issued | 2031-06-11 |