CEFALY Technology
BE-MF-000011545 · Belgium · Liège
CEFALY Technology is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: 10602,10603,10604,10605,10606,10607,10608,10609,, 11301, 11302.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- CEFALY
- CEFALY Dual
- Cefaly
Catalogue references include 10503,10504,10505,10506,10507,10508,10509,10510,10511,10512,10513,1051, 10602,10603, 10604, 10605, 10606 , 10607 ,10608 ,10609,, 11301, 11302.
European nomenclature codes declared: N010201, N010201,N010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CEFALY TECHNOLOGY (BE) · FDA 3010188009 |
| Devices in EUDAMED | 6 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CEFALY TECHNOLOGY |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2010-11-30 |
Licence types: System (3), Device Group (1).
Licensed under: CEFALY (GENERATEUR D'IMPULSIONS ELECTRIQUES DE, CEFALY ENHANCED, CEFALY CONNECTED, ELECTRODES.
North American profile: Both markets. CEFALY Technology is registered in both the United States and Canada.