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 IIa | 3 |
|---|---|
| Class I | 15 |
| Class IIb | 1 |
Among these devices, 19 are declared sterile.
Devices declared under this manufacturer
- GM501 Collagenase
- GM501 Culture
- GM501 Culture 20ml
- GM501 Culture mit Gentamycin 20ml
- GM501 Culture mit Phenolrot u. Gentamycin
- GM501 Flush
- GM501 Flush 100 ml
- GM501 Flush 20 ml
- GM501 Flush 250 ml
- GM501 Flush 500 ml
- GM501 Hyaluronidase 10 ml
- GM501 Mineral Oil
Showing 12 of 19 declared devices.
Catalogue references include 4 GM 501F-100, 4 GM 501F-250, 4 GM 501H+G-20, 4 GM 501H+PR+G-50, 4 GM 501H-50, 4 MO 0250.
European nomenclature codes declared: U08020502, U08020503.
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 |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| 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. Gynemed GmbH & Co. KG is registered in the United States but was not found in the Canadian register.