Circius Pharma AB
SE-MF-000013023 · Sweden · Askim
Circius Pharma AB is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: G1.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- Otinova
- Otovent
- Tinearity G1
- Tinearity G1 Adapters x3
Showing 12 of 24 declared devices.
Catalogue references include 50106, 50507, 50508, 51501, 6000, 6006.
European nomenclature codes declared: Q03040199, Q030499, Z129013.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CIRCIUS PHARMA AB (SE) · FDA 3021916254 |
| Devices in EUDAMED | 24 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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: United States only. Circius Pharma AB is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620230086 | supplemented | 2030-11-05 |