MED.e.Com
FR-MF-000003036 · France · PLOUGASTEL-DAOULAS
MED.e.Com is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: MEDWS, MEDXRAY.
Among these devices, 11 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- MEDWS
- MEDWS 6.1
- MEDWS 6.4
- MEDXR
- MEDXRAY 5.1
- MEDXRAY 6.3
- Med X-Ray 7.1
Catalogue references include 7.1, 7.4, MEDWS, MEDWS 6.4, MEDWS 7.6, MEDXRAY.
European nomenclature codes declared: V92, Z11069092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDECOM (FR) · FDA 3010966991 |
| Devices in EUDAMED | 11 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 36.4 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. MED.e.Com is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FR25/00000027 | amended | 2030-01-20 |