PROMECON GmbH
DE-MF-000015290 · Germany · Hamburg
PROMECON GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 18 |
|---|
Among these devices, 15 are declared sterile.
Devices declared under this manufacturer
- CareVis Bag I/L
- CareVis Bag S/M
- CareVis Bag X/G
- KRYSTAL
- OptiGuard Access
- OptiGuard QuickChange Arthro
- OptiGuard QuickChange Pro
- SonoGuard
- SonoGuard Plus
Showing 12 of 18 declared devices.
Catalogue references include OG.10.130.250, OG.41.180.250, SG.10.140.025, SG.10.140.040, SG.10.140.160, SG.20.180.040.
European nomenclature codes declared: T030199, A0580.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 | 18 |
|---|---|
| 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. PROMECON GmbH was not found in either the U.S. or the Canadian register.