Gentian AS
NO-MF-000003448 · Norway · Moss
Gentian AS is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 1101, 1201, 1701.
Devices declared under this manufacturer
- GCAL®NEPH Calibrator
- GCAL®NEPH Calprotectin
- GCAL®NEPH Controls
- Gentian Cystain C Control Kit
- Gentian Cystatin C Calibrator
- Gentian Cystatin C Calibrator Kit
- Gentian Cystatin C Control Kit
- Gentian Cystatin C Reagent Kit
- Gentian Cystatin C Reagent Kit for the Beckman Coulter AU Systems
- Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel
- Gentian GCAL® Calprotectin Calibrator Kit
- Gentian GCAL® Calprotectin Control Kit
Showing 12 of 16 declared devices.
Catalogue references include 1019, 1026, 1051, 1100 / A52761, 1201, 1202.
European nomenclature codes declared: W0102152003, W0102152203, W0102019008, W0102019009.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Gentian AS (NO) · FDA 3006801241 |
| Devices in EUDAMED | 16 |
| Country of registration | Norway |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 56.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GENTIAN AS |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2008-07-23 |
Licence types: Device Family (2), Test Kit (1).
Licensed under: GENTIAN CYSTATIN C CALIBRATOR KIT, GENTIAN CYSTATIN C IMMUNOASSAY, GENTIAN CYSTATIN C CONTROL KIT.
North American profile: Both markets. Gentian AS is registered in both the United States and Canada.