LED SpA
IT-MF-000012232 · Italy · LT
LED SpA is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 54 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: HANDY, SURTRON LASER 8, SURTRON TOUCH HP 400, carbomed CO2, combisan.
Among these devices, 59 are declared active.
Devices declared under this manufacturer
- COOLINGBIS 1.0
- DIATERMO MB 132
- DIATERMO MB 200
- DIATERMO MB 200 F
- DIATERMO MB 300 T
- SURTRON 80D
- SURTRON SB
- SURTRON TOUCH 400
- SURTRON TOUCH HP 400
- SURTRON TOUCH HP 50D
- carbomed CO2
- lambda 2
Showing 12 of 60 declared devices.
Catalogue references include 10100.081, 10100.T05, CRB001, GMA10100.40, GMA10300.10, LMB002.
European nomenclature codes declared: Z12010902, Z12030399, Z12139001, Z120615, Z120601,Z120610,Z12069080, Z120606,Z120615,Z12069080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LED SPA (IT) · FDA 3006411077 |
| Devices in EUDAMED | 60 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 60 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 8.3 % |
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. LED SpA is registered in the United States but was not found in the Canadian register.