biosurfit SA
PT-MF-000033920 · Portugal · Azambuja
biosurfit SA is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: AHLTTA, AHLTTRTA, AHLTUS, CHARM01, spinit® BC control.
Devices declared under this manufacturer
- At-home Lab Testing
- CHARMcm®
- spinit®
- spinit® S
Showing 12 of 17 declared devices.
Catalogue references include 240300, 910101, 910201, 910301, 950200, AHLT_003.
European nomenclature codes declared: W0501010280, W0299, W0501010299, W0103080402, W01021109, W050180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Portugal |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| 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. biosurfit SA was not found in either the U.S. or the Canadian register.