Termosalud, S.L.
ES-MF-000019177 · Spain · Gijón
Termosalud, S.L. is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 66 |
|---|---|
| Class IIa | 5 |
Most frequent device types declared: CAP ELECTRODE WAVE 13MM SEA/SP, ENEKA PRO AESTHETIC, HP-V, LARGE FOLD AESTHETIC HP, RES DEEP ACTION FOCUS.
Among these devices, 67 are declared active.
Devices declared under this manufacturer
- CHROMIX
- DIODE LASER AE 2XL HANDPIECE: 5000W-30x12MM-810NM
- DIODE LASER AE L HANDPIECE: 2000W-10x9MM-755NM
- DIODE LASER AE L HANDPIECE: 2000W-10x9MM-810NM
- DIODE LASER AE XL HANDPIECE: 4000W-20x9MM-3WL
- DIODE LASER AE XL HANDPIECE: 4000W-20x9MM-755NM
- ENEKA PRO
- ENEKA PRO AESTHETIC
- INÜO
- RF NEUTRAL CREAM
- SYMMED ELITE AESTHETIC
- VMAT PRO AESTHETIC
Showing 12 of 71 declared devices.
Catalogue references include A2181AE, A439AE, A440AE, A446AE, AR000079140AE, AR00010349.
European nomenclature codes declared: Z12040203, Z120615, Z12139001, M9001, Z12062801, M04041503.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TERMOSALUD S.L. (ES) · FDA 3026400760 |
| Devices in EUDAMED | 71 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 71 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 7.0 % |
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. Termosalud, S.L. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
240/MDR | supplemented | 2030-10-12 |