ACTEON MANUFACTURING
FR-MF-000007556 · France · MERIGNAC
ACTEON MANUFACTURING is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 78 |
|---|---|
| Class I | 2 |
Among these devices, 3 are declared sterile, 6 implantable.
Devices declared under this manufacturer
- Art by RISKONTROL
- EXPASYL (Fraise / strawberry flavor) x20
- EXPASYL x20
- EXPASYL x6
- Expasyl Canules/cannulas
- HEMOSTASYL Canules/cannulas
- RISKONTROL ADEC INOX
- RISKONTROL CASTELLINI V
- RISKONTROL DENTALEZ
- RISKONTROL KAVO K
- RISKONTROL LU NEW INOX
- RISKONTROL TAKARA BELMONT
Showing 12 of 80 declared devices.
Catalogue references include 200163, 200193, 201702, 201750, 261005, 261030.
European nomenclature codes declared: Q0199, Q010204, Q01010202, Q010399, Q01010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ACTEON MANUFACTURING (FR) · FDA 3003677417 |
| Devices in EUDAMED | 80 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 80 |
|---|---|
| Found in the U.S. device database | 26 |
| Share | 32.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ACTEON MANUFACTURING |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2017-02-03 |
Licence types: System (1), Device Family (1).
Licensed under: EXPASYL, EXPASYL EXACT.
North American profile: Both markets. ACTEON MANUFACTURING is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40031 | supplemented | 2029-10-09 |
39305 | supplemented | 2028-05-24 |