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: AQ-Flex™19 N, AlveoFlex™ N, AlveoFlex™N, CelioFlex ™ 5 N, Cellvizio® I.V.E..
Among these devices, 4 are declared reusable, 2 active.
Devices declared under this manufacturer
- AQ-Flex™ 19 N
- AlveoFlex™ N
- AlveoFlex™N
- CelioFlex ™ 5 N
- Cellvizio® I.V.E.
- CholangioFlex™ N
- ColoFlex™N
- CystoFlex™ F N
- CystoFlex™ R N
- CystoFlex™R N
- GastroFlex™ N
- UroFlex™ N
Showing 12 of 20 declared devices.
Catalogue references include FP-10001, FP-10029, FP-10030, FP-10031, FP-10032, FP-10033.
European nomenclature codes declared: Z12020785, Z12029085, Z12020585, Z12020685, Z12020885, Z12020401.
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 |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MAUNA KEA TECHNOLOGIES |
North American profile: Both markets. MAUNA KEA TECHNOLOGIES is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40429 | supplemented | 2031-02-04 |