Insulcloud S.L.
ES-MF-000004510 · Spain · Bilbao
Insulcloud S.L. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: INSULCLOCK V2.0 LITE, Insulclock 360 - iOs.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- INSULCLOCK 360
- INSULCLOCK V2.0 LITE F
- INSULCLOCK V2.0 LITE FT
- INSULCLOCK V2.0 LITE KW
- INSULCLOCK V2.0 LITE S
- Insulcap Go
Catalogue references include 440001, 440002, 440003, 440004, 610011, INGo_Lantus.
European nomenclature codes declared: V9099, Z12040192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Insulcloud S.L. was not found in either the U.S. or the Canadian register.