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
| other | 19 |
|---|
Most frequent device types declared: 420-10, 220-10, 120-10, 101-10, 240-20.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1060415-1 | supplemented | 2029-01-11 |