Biocool AB
SE-MF-000012411 · Sweden · Stockholm
Biocool AB is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Devices declared under this manufacturer
- Almirall MyFungar Medizinisches Fußbad
- BIOpH+ Footcare
- BIOpH+ Medical foot bath
- BIOpH+ Psoriasis medical bath
Catalogue references include 1000001, 10000012, 1000002, 1000008, BPPFC1250EU, BPPFC250EU.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 7 |
|---|---|
| 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. Biocool AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620160593 | issued | 2028-10-05 |