Roche Diabetes Care GmbH
DE-MF-000006276 · Germany · Mannheim
Roche Diabetes Care GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 2 |
|---|
Most frequent device types declared: Model NC.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- Accu-Chek
- Accu-Chek Aviva
- Accu-Chek Guide
- Accu-Chek Insight
- Accu-Chek Instant
- Accu-Chek Mobile
- Accu-Chek Solo
- Accu-Chek Spirit Combo
Catalogue references include 06383602028, 06988709170, 07249241001, 07864175001, 08116113370, 08433232001.
European nomenclature codes declared: Z1204011502, Z120402160102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Roche Diabetes Care GmbH (DE) · FDA 3011806823 |
| Devices in EUDAMED | 10 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ROCHE DIABETES CARE AG |
North American profile: Both markets. Roche Diabetes Care GmbH is registered in both the United States and Canada.