Fujirebio Diagnostics AB
SE-MF-000007811 · Sweden · Mölndal
Fujirebio Diagnostics AB 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
Most frequent device types declared: 101-10, 107-20, 120-10, 200-10, 220-10.
Devices declared under this manufacturer
- AMH Control
- CYFRA 21-1 EIA
- CanAg AFP EIA
- CanAg CA15-3 EIA
- CanAg CA19-9 EIA
- CanAg CA242 EIA
- CanAg CEA EIA
- CanAg Free PSA EIA
- CanAg NSE EIA
- CanAg PSA EIA
- CanAg ProGRP EIA
- CanAg S100 EIA
Showing 12 of 19 declared devices.
Catalogue references include 101-10, 120-10, 211-10, 220-10, 240-20, 350-10.
European nomenclature codes declared: W01021521, W0102039007, W0102030111, W0102030121, W0102152099, W0102030103.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Fujirebio Diagnostics AB (SE) · FDA 3027273565 |
| Devices in EUDAMED | 19 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 21.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FUJIREBIO DIAGNOSTICS, INC. |
North American profile: Both markets. Fujirebio Diagnostics AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1060415-1 | supplemented | 2029-01-11 |