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
Devices declared under this manufacturer
- CoaguChek INRange
- CoaguChek XS System
- Elecsys CK-MB
- Elecsys IGRA TB
- Elecsys PTH
- IGRA TB CS Elecsys
- VENTANA PD-L1 (SP263) Assay
- VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
- VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody
- VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody
- VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
- VENTANA anti-PMS2 (SP487) Mouse Monoclonal Primary Antibody
Showing 12 of 16 declared devices.
Catalogue references include 04625412170, 07027087214, 08033692001, 09605584001, 09607137001, 09607161001.
European nomenclature codes declared: W01030709, W02020602, W0105080901, W01021311, W0105010704, W0102060312.
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 |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ROCHE DIAGNOSTICS |
North American profile: Both markets. Roche Diagnostics GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V76 010283 0738 | supplemented | 2029-11-20 |
V75 010283 0684 | supplemented | 2029-03-27 |