B. Braun Avitum AG
DE-MF-000005127 · Germany · Melsungen
B. Braun Avitum AG is registered in the European database on medical devices as a manufacturer, with 268 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 211 |
|---|---|
| Class IIa | 57 |
Among these devices, 61 are declared sterile, 152 active.
Devices declared under this manufacturer
- AQUAbase®
- AQUAboss®
- B.Braun
- DiaStream ® iQ Premium
- DiaStream®
- Diacan®
- Diacap®
- Dialog iQ®
- Nexadia®
- OMNIbag®
- OMNIset®
- OMNI®
Showing 12 of 268 declared devices.
Catalogue references include 6924, 7211279, 7211425, 7211609, 903, LA1101325.
European nomenclature codes declared: Z12099007, F040101, F020102, F0306, Z12090201, Z12090280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | B. Braun Avitum AG (DE) · FDA 3004176176 |
| Devices in EUDAMED | 268 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 268 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 3.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | B. BRAUN AVITUM AG |
What it holds in Canada
| Licences on record | 34 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 19 |
| Class 3 devices | 14 |
| Class 4 devices | 1 |
| First licensed | 1999-12-06 |
Licence types: Device Family (16), System (8), Single Device (8), Device Group (1).
Licensed under: DIAPACT CRRT, H.E.L.P. (HEPARIN-INDUCED EXTRACORPOREAL LIPOP, DIALOG+ DIALYSIS MACHINES, AQUABOSS ECORO DIA 50, A/V HEMODIALYSIS TUBING SETS, DIACAP ALPHA POLYSULFONE DIALYZERS.
North American profile: Both markets. B. Braun Avitum AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 066097 0125 | issued | 2030-10-01 |