Intigena GmbH & Co.KG.
DE-MF-000004948 · Germany · Mülheim an der Ruhr
Intigena GmbH & Co.KG. is registered in the European database on medical devices as a manufacturer, with 102 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 102 |
|---|
Most frequent device types declared: Inkontienenz Slipeinlagen, Inkontinenz Pull-On Pants, Inkontinenz-Einlagen.
Devices declared under this manufacturer
- BiComfort
- Clever
- INEA
- Loft
- Royal Excellence
- Sana
- Satessa
- Satessa Discreet
- Satessa Diskreet
- Satessa Diskret
- Satessa discreet
- Secure
Showing 12 of 102 declared devices.
Catalogue references include 04013209000395, 04013209000463, 04013209000623, 04013209001002, 04013209001385, 04013209001408.
European nomenclature codes declared: T99, T04010199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 102 |
| 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 | 102 |
|---|---|
| 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. Intigena GmbH & Co.KG. was not found in either the U.S. or the Canadian register.