Roche Diagnostics GmbH
DE-MF-000006260 · Germany · Mannheim
Roche Diagnostics GmbH 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
| other | 16 |
|---|
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 | ROCHE DIAGNOSTICS GMBH (DE) · FDA 9610126 |
| Devices in EUDAMED | 16 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V76 010283 0738 | supplemented | 2029-11-20 |
V75 010283 0684 | supplemented | 2029-03-27 |