Occlutech GmbH
DE-MF-000005104 · Germany · Jena
Occlutech GmbH is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 65 |
|---|
Among these devices, 65 are declared sterile, 50 implantable.
Devices declared under this manufacturer
- Figulla Flex II ASD
- Figulla Flex II PFO
- Figulla Flex II UNI
- Occlutech Delivery Set
- Occlutech Occlusions Pusher
- Occlutech Sizing Balloon
Showing 12 of 65 declared devices.
Catalogue references include 16UNI33, 19PFO30D, 19PFO35D, 29ASD21, 29ASD24, 29ASD39.
European nomenclature codes declared: P07040302, C0502, P07040303, P0780, C99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Occlutech GmbH (DE) · FDA 3014616394 |
| Devices in EUDAMED | 65 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 65 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OCCLUTECH GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 4 devices | 2 |
| First licensed | 2013-03-05 |
Licence types: Device Group Family (3), Device Group (1).
Licensed under: OCCLUTECH SIZING BALLOON, OCCLUTECH DELIVERY SET, FIGULLA FLEX II ASD OCCLUDER, FIGULLA FLEX II PFO.
North American profile: Both markets. Occlutech GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
51030-61-D0-00 | issued | 2031-05-06 |
51030-61-C0 | issued | 2028-06-28 |
51030-61-B0 | issued | 2028-06-28 |
51030-61-A0 | issued | 2027-09-01 |
51030-60-00-01 | supplemented | 2026-10-19 |