Burman Enterprise
SE-MF-000048669 · Sweden · Jonkoping
Burman Enterprise is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: B08M9DQ5T8, B08WYMQNDP, B09DHQDZZB, B09LLMP3XL, B0CFJ73574.
Catalogue references include B09LLMP3XL, B09LLPDTYV, B09LLX9XNY, B09LV4M578, B0C3LLBGM2, Elbow Sleeve.
European nomenclature codes declared: Y061218, M03040299, Y061209, Y061299, Y060615.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| 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. Burman Enterprise was not found in either the U.S. or the Canadian register.