icometrix
BE-MF-000006329 · Belgium · Leuven
icometrix is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 8 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- icobrain ct
- icobrain ctp
- icobrain mr
- icompanion
Catalogue references include 1.7.z, 2.1.z, 2.2.z, 5.15.z, 5.16.z, 5.17.z.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | icometrix (BE) · FDA 3013427569 |
| Devices in EUDAMED | 8 |
| Country of registration | Belgium |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ICOMETRIX NV |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2018-04-26 |
Licence types: Single Device (2).
Licensed under: ICOBRAIN, ICOMPANION.
North American profile: Both markets. icometrix is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE23/00000345 | issued | 2028-12-11 |