E.M.S. Electro Medical Systems S.A.
CH-MF-000026136 · Switzerland · Nyon
E.M.S. Electro Medical Systems S.A. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 19 |
|---|
Most frequent device types declared: DS-521A, FT-216#, FT-300.
Among these devices, 16 are declared active.
Authorised representative in the Union: EMS FRANCE SARL.
Devices declared under this manufacturer
- GBT Machine AIRFLOW Prophylaxis Master
- Instrument PS MAX
- Instrument PS MAX x3
- Instruments PS MAX PSL PSR
- PIEZON 250
Showing 12 of 19 declared devices.
Catalogue references include DS-521A, DS-521A/T, FS-502, FT-216, FT-224, FT-300.
European nomenclature codes declared: Z12119001.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (CH) · FDA 8030987 |
| Devices in EUDAMED | 19 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 10.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
What it holds in Canada
| Licences on record | 30 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 26 |
| Class 3 devices | 4 |
| First licensed | 1999-09-01 |
Licence types: System (13), Device Group Family (8), Single Device (5), Device Family (3).
Licensed under: PIEZON HANDPIECES, AIRFLOW SI SYSTEM, SWISS DOLORCLAST SYSTEM, AIRFLOW HANDY, AIRFLOW NOZZLE, PIEZON TIPS AND FILES.
North American profile: Both markets. E.M.S. Electro Medical Systems S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
50081-60-01-00 | reissued | 2030-06-17 |