Salofa Oy
FI-MF-000016823 · Finland · Salo
Salofa Oy is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: 120 cm, 120 cm FS, 20 cm, 40 cm, 40 cm, 2 valves.
Among these devices, 9 are declared sterile.
Devices declared under this manufacturer
- CT Filling Set 120 cm
- CT Patient Line 120 cm (300 psi)
- CT Patient Line 20 cm (300 psi)
- CT Patient Line 40 cm (300 psi)
- CT Patient Line 40 cm (300 psi), 2 valves
- CT Patient Line 40 cm (300 psi), 2 valves, RA
- CT Patient Line 75 cm (300 psi)
- CT Patient Line 75 cm (300 psi), 2 valves
- CT Patient Line 75 cm (300 psi), soft
- Reader-1-S
Showing 12 of 31 declared devices.
Catalogue references include CLA-COV19AG-VIS, COV-06-S, COV-07-S, CTPL020RV-H, CTPL040RV2-HR, CTPL120RV-H.
European nomenclature codes declared: A030499, W0105099099, W0102160203, W0102160511, W0102160599, W0105090103.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SALOFA OY (FI) · FDA 3016820006 |
| Devices in EUDAMED | 31 |
| Country of registration | Finland |
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. Salofa Oy is registered in the United States but was not found in the Canadian register.