Actim Oy
FI-MF-000024323 · Finland · Espoo
Actim Oy is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 30322ETAC, 30831ETAL, 30832ETAC, 30832ETAL, 31032ETPL.
Devices declared under this manufacturer
- Actim 1ngeni
- Actim 1ngeni Instrument Check
- Actim Combi® Hemoglobin Transferrin
- Actim® CRP
- Actim® Calprotectin
- Actim® Calprotectin Controls
- Actim® Influenza A&B
- Actim® PROM
- Actim® PROM Controls
- Actim® PROM Test
- Actim® Pancreatitis
- Actim® Pancreatitis Controls
Showing 12 of 41 declared devices.
Catalogue references include 30322ETAC, 30831ETAL, 30832ETAC, 31032ETPL, 31034ETPL, 31931RETAL.
European nomenclature codes declared: W01021699, W0102160801, W0102160601, W0102160203, W0105099004, W0102160199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ACTIM OY (FI) · FDA 1000212994 |
| Devices in EUDAMED | 41 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 2 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ACTIM OY |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2002-08-08 |
Licence types: Test Kit (2).
Licensed under: ACTIM PROM, ACTIM PARTUS TEST.
North American profile: Both markets. Actim Oy is registered in both the United States and Canada.