Serumwerk Bernburg AG
DE-MF-000005169 · Germany · Bernburg
Serumwerk Bernburg AG is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 33 |
|---|---|
| Class IIb | 7 |
Most frequent device types declared: Balanced salt solution, Bicarbonate Cartridges for Haemodialysis, Sterile Tubing Sets for Hemodialysis and Disposables.
Among these devices, 33 are declared sterile.
Devices declared under this manufacturer
- A-SN/V/799/SFR/22/R
- A/V-SN/2000/NI/R (K)
- AV/10100/HDF/SGA/R
- AV/2/FGH/S/R
- AV/2000/NI/R (K)
- AV/721/SFR/22/R
- AV/SN10100/SGA/R
- BSS DISTRA-SOL
- DiaCart 720 g OP/F/C
- DiaCart 750 g OP/F/C
- EA SOL BALANCED SALT SOLUTION
- Eye-Lotion Balanced salt solution
Showing 12 of 40 declared devices.
Catalogue references include 1034, 1222, 1247, 1249, 1250, 1251.
European nomenclature codes declared: F020199, Q02030203, F040201, V0999.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 40 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 40 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Serumwerk Bernburg AG was not found in either the U.S. or the Canadian register.