Gynemed GmbH & Co. KG
DE-MF-000005264 · Germany · Sierksdorf
Gynemed GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 15 |
|---|---|
| Class IIa | 3 |
| Class IIb | 1 |
Among these devices, 19 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GYNEMED GMBH & CO. KG (DE) · FDA 3030390242 |
| Devices in EUDAMED | 19 |
| Country of registration | Germany |