APELEM
FR-MF-000008953 · France · Gallargues-le-Montueux - FRANCE
APELEM is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 14 |
|---|
Most frequent device types declared: STRATOS .
Among these devices, 12 are declared active, 12 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 | APELEM (FR) · FDA 9616491 |
| Devices in EUDAMED | 14 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.26/6188 | issued | 2031-06-08 |