Entlab Oy
Country not established
- Devices
- 1
What Entlab Oy makes
Entlab OY manufactures the ULTRAMAX (Model A1), a Class II medical device designed for diagnostic or monitoring purposes in a specialized clinical setting.
The ULTRAMAX (Model A1) is regulated under the FDA’s 510(k) pathway as a Class II device and is listed in the FDA registry. The company is based in the United States.
Catalogue
Ultramax/Model Number A1 Ref K960044
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entlab OY have in the registry?
The registry currently lists 1 device for Entlab OY. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entlab OY's devices?
Among its 1 most recently registered device, Entlab OY has devices listed in FDA 510(k) (1 device).
What risk classes do Entlab OY's devices fall under?
Among its 1 most recently registered device, the classes recorded for Entlab OY's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entlab OY in the registry?
The most recently registered devices listed for Entlab OY include ULTRAMAX/MODEL NUMBER A1.