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.
Devices declared under this manufacturer
- FDX Visionary-A (compact version)
- FDX Visionary-A (standard version)
- FDX Visionary-DR
- MEDIX DR
- MEDIX90 (Standard version)
- MEDIX90 (compact version)
- ONYX
- RADIOSCORE (compact version)
- RADIOSCORE (standard version)
- RADIOSCORE dR
- STRATOS
- STRATOS (compact version)
Showing 12 of 14 declared devices.
Catalogue references include 5W, 7H, 7Z, 8T, NA.
European nomenclature codes declared: Z11900103, Z11039016.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | APELEM (FR) · FDA 9616491 |
| Devices in EUDAMED | 14 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | APELEM SAS |
North American profile: Both markets. APELEM is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.26/6188 | issued | 2031-06-08 |