Devyser AB
SE-MF-000001699 · Sweden · Årsta
Devyser AB is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- Advyser Solid Organs
- Devyser AZF Extension
- Devyser AZF v2
- Devyser BRCA
- Devyser CFTR 68
- Devyser Compact
- Devyser Compact v3
- Devyser Complete v2
- Devyser Extend v2
- Devyser HBOC
- Devyser HFE v2
- Devyser RHD
Showing 12 of 50 declared devices.
Catalogue references include 8-A012.2-XY, 8-A015.2-100, 8-A017.3-50, 8-A030.2, 8-A035, 8-A045-24.
European nomenclature codes declared: W0106010399, W01060299, W0106010101, W0106010499, W0580, W0106010111.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 50 |
| 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 | 50 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DEVYSER AB |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2023-05-09 |
Licence types: Test Kit (2).
Licensed under: DEVYSER RHD, ONE LAMBDA DEVYSER CHIMERISM.
North American profile: Canada only. Devyser AB holds a Canadian licence but was not found in the U.S. register.