AKLA AB
SE-MF-000004567 · Sweden · Askersund
AKLA AB 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 IIb | 10 |
|---|---|
| Class IIa | 5 |
Among these devices, 8 are declared sterile.
Catalogue references include 94297, 94367, 94370, 94373, 94375, 94377.
European nomenclature codes declared: M04040501.
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 | 1 |
|---|---|
| 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. AKLA AB was not found in either the U.S. or the Canadian register.