KOELIS
FR-MF-000000830 · France · MEYLAN
KOELIS is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: Steady Pro, TRINITY, Reusable PERINE guides, Con Lead and Lin Lead guides, Nail.
Among these devices, 1 are declared sterile, 8 active, 7 with a measuring function.
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 | KOELIS (FR) · FDA 3008487708 |
| Devices in EUDAMED | 31 |
| Country of registration | France |