NordicNeuroLab AS
NO-MF-000000555 · Norway · Bergen
NordicNeuroLab AS is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 19 |
|---|
Most frequent device types declared: 1.0, 1.2, 1.3, 2.0, 2.3.
Among these devices, 17 are declared active.
Devices declared under this manufacturer
- Control Room Interface (CRI)
- InroomViewingDevice
- ResponseGrip Interface (RGI)
- ResponseGrips
- Visual System Power Supply (VPS)
- VisualSystem HD
- VisualSystem Power Cable (VPC)
- nordicAktiva
- nordicAudio 1,5T
- nordicAudio 3T
- nordicAudio AccessPoint
- nordicAudio AudioHub
Showing 12 of 19 declared devices.
Catalogue references include 1.3, 102123, 102125, 2.0, 4.0, 800059.
European nomenclature codes declared: Z11020780, Z11020782, Z11020792.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NORDICNEUROLAB AS (NO) · FDA 3006738448 |
| Devices in EUDAMED | 19 |
| Country of registration | Norway |
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 94.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NORDICNEUROLAB AS |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2011-04-08 |
Licence types: Single Device (1).
Licensed under: NORDICBRAINEX.
North American profile: Both markets. NordicNeuroLab AS is registered in both the United States and Canada.