MAUNA KEA TECHNOLOGIES
FR-MF-000000835 · France · Paris
MAUNA KEA TECHNOLOGIES is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 20 |
|---|
Most frequent device types declared: UroFlex™ N, GastroFlex™N, AQ-Flex™19 N, CholangioFlex™N, Cellvizio® I.V.E..
Among these devices, 4 are declared reusable, 2 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAUNA KEA TECHNOLOGIES (FR) · FDA 3004542960 |
| Devices in EUDAMED | 20 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40429 | supplemented | 2031-02-04 |