Epitest Ltd. Oy
Country not established
- Devices
- 1
What Epitest Ltd. Oy makes
Epitest Ltd. OY manufactures the Finn Chamber (R), a Class I medical device designed for diagnostic or sample collection purposes in clinical settings.
The Finn Chamber (R) is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the U.S. regulatory database. The company is based in Finland.
Catalogue
Finn Chamber (R) Ref K013820
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Epitest Ltd. OY have in the registry?
The registry currently lists 1 device for Epitest Ltd. OY. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epitest Ltd. OY's devices?
Among its 1 most recently registered device, Epitest Ltd. OY has devices listed in FDA 510(k) (1 device).
What risk classes do Epitest Ltd. OY's devices fall under?
Among its 1 most recently registered device, the classes recorded for Epitest Ltd. OY's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Epitest Ltd. OY in the registry?
The most recently registered devices listed for Epitest Ltd. OY include FINN CHAMBER (R).