Bernhard Klein e.K.
DE-MF-000021891 · Germany · Bremen
Bernhard Klein e.K. is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 30 |
|---|
Most frequent device types declared: BIORELAX Produktfamilie Magnetfolien.
Devices declared under this manufacturer
- Biorelax Autositzauflage
- Biorelax Einlegesohle Gr. 37
- Biorelax Einlegesohle Gr. 41
- Biorelax Einlegesohle Gr. 43
- Biorelax Einlegesohle Gr. 44
- Biorelax Einlegesohle Gr. 46
- Biorelax Pad 22cm
- Biorelax Pad 40cm
- Muster Sitzauflage Bianca grau 50x100
- Zubehör Biorelax Armband 40cm
- Zubehör CE Herzschrittmacherauflage
- Zubehör Rückenbandage 104cm
Showing 12 of 30 declared devices.
Catalogue references include 4260324140196, 4260324140752, 4260324140783, 4260324140806, 4260324141049, 4260324141056.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 30 |
| 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 | 30 |
|---|---|
| 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. Bernhard Klein e.K. was not found in either the U.S. or the Canadian register.