Isansys Lifecare Ltd
GB-MF-000022154 · United Kingdom · Dicot
Isansys Lifecare Ltd is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: PSE_2.
Among these devices, 16 are declared active, 16 with a measuring function.
Authorised representative in the Union: Isansys Lifecare Europe GmbH.
Devices declared under this manufacturer
- Isansys
Showing 12 of 16 declared devices.
Catalogue references include Gateway T585 GSM, Isansys Patient Gateway T510 - 10.1 Screen - WIFI, Lifeguard Server, Lifetemp Sensor - V2 - Large, Lifetemp Sensor - V2 - Medium, Lifetemp Sensor V2 Small.
European nomenclature codes declared: V0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 87.5 % |
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. Isansys Lifecare Ltd was not found in either the U.S. or the Canadian register.