Innoventa Medica ApS
DK-MF-000013980 · Denmark · Birkeroed
Innoventa Medica ApS is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 3 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: 1050, 9FR, Extension tube ENFit.
Among these devices, 4 are declared sterile, 2 implantable.
Devices declared under this manufacturer
- Extension tube ENFit 15 cm.
- Extension tube ENFit 20 cm.
- Extension tube ENFit 30 cm.
- Extension tube ENFit 80 cm.
- Extension tube ENFit/Luer 27 cm.
- Handset
- Lecigon PEG J, Enfit
Catalogue references include 1050, 2109, 2115, 2120, 215015, 215030.
European nomenclature codes declared: A03020199, G02020201, A06010199, G02020202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INNOVENTA MEDICA (DK) · FDA 3009156861 |
| Devices in EUDAMED | 9 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 11.1 % |
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. Innoventa Medica ApS is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620173712 | issued | 2028-03-20 |
28620146168 | issued | 2028-03-20 |