Biosys AB (Publ)
Country not established
- Devices
- 2
What Biosys AB (Publ) makes
Biosys AB (Publ) manufactures the BIOSACA SYSTEM, including the Model 800 variant, which is designed for medical applications requiring controlled fluid transfer or sacral pressure management.
The BIOSACA SYSTEM is classified as a Class II medical device under FDA regulations and is listed in the 510(k) registry. The company is based in the United States.
Catalogue
Biosaca System, Model 800 Ref K991446
Regimes: 510(k) Registry: 510(k)Biosaca System Ref K984580
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosys AB (Publ) have in the registry?
The registry currently lists 2 devices for Biosys AB (Publ). Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosys AB (Publ)'s devices?
Among its 2 most recently registered devices, Biosys AB (Publ) has devices listed in FDA 510(k) (2 devices).
What risk classes do Biosys AB (Publ)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biosys AB (Publ)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosys AB (Publ) in the registry?
The most recently registered devices listed for Biosys AB (Publ) include BIOSACA SYSTEM, MODEL 800 and BIOSACA SYSTEM.