Bio-Rad Medical Diagnostics GmbH
DE-MF-000019864 · Germany · Dreieich
Bio-Rad Medical Diagnostics GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Alsevers F
- MLB 2
- Rinderalbumin 22%
- Rinderalbumin 30%
Catalogue references include 12014332, 805060, 805090, 805200, 805205, 806505.
European nomenclature codes declared: W0103030306, W010399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIO-RAD MEDICAL DIAGNOSTICS GMBH (DE) · FDA 9610824 |
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 9 |
| First licensed | 2006-03-24 |
Licence types: Device Family (5), Single Device (3), Test Kit (1).
Licensed under: MLB 2 MODIFIED LISS, ANTI-HUMAN-GLOBULIN, SERACLONE BLOOD GROUPING REAGENTS, BIOTESTCELL, BIOTESTCELL A1, A2, B, 0, CONTROL SERA BLOOD GROUPING.
North American profile: Both markets. Bio-Rad Medical Diagnostics GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V12 118577 0011 | supplemented | 2027-03-08 |
HX 1037243-1 | cancelled | 2027-03-08 |