B. Braun Melsungen AG
DE-MF-000000201 · Germany · Melsungen
B. Braun Melsungen AG is registered in the European database on medical devices as a manufacturer, with 966 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 965 |
|---|---|
| Class IIb | 1 |
Among these devices, 910 are declared sterile, 63 active, 157 with a measuring function.
Devices declared under this manufacturer
- Discofix® C
- Injekt® Luer Duo
- Intrafix® Primeline
- Introcan® Certo
- Introcan®-W
- Omnican® 50
- Oral Dispenser
- Original Perfusor® Line
- ProSet Cyto-Set® Mix
- ProSet Discofix® C
- ProSet Intrafix® SafeSet
- ProSet Original Perfusor® Line
Showing 12 of 966 declared devices.
Catalogue references include 4092930, 4180459, 4186109, 4187529, 4188550, 4254074B.
European nomenclature codes declared: A03010105, A0703, A03020101, A04010101, C0101010102, A03010101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | B. BRAUN MELSUNGEN AG (DE) · FDA 9610825 |
| Devices in EUDAMED | 966 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 966 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 0.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | B. BRAUN MELSUNGEN AG |
What it holds in Canada
| Licences on record | 38 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 35 |
| Class 3 devices | 3 |
| First licensed | 1999-07-28 |
Licence types: Device Family (24), Device Group Family (8), System (3), Single Device (2).
Licensed under: NEEDLES FOR ACCESS PORTS, I.V. CANNULA, DISCOFIX STOPCOCKS AND MANIFOLDS, MINI-SPIKE IV ADDITIVE DISPENSING PINS, INTROCAN SAFETY IV CATHETER, STERICAN HYPODERMIC NEEDLES FOR SINGLE USE.
North American profile: Both markets. B. Braun Melsungen AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 012974 0679 | supplemented | 2030-12-16 |
G12 012974 0651 | supplemented | 2028-10-11 |
G12 012974 0638 | supplemented | 2028-04-05 |
G11 012974 0626 | supplemented | 2026-12-14 |
G10 012974 0611 | supplemented | 2030-03-12 |