Gnali Bocia S.r.l.
ItalyFDA applicant, unverified
- Devices
- 1
What Gnali Bocia S.r.l. makes
Gnali Bocia S.R.L. manufactures the Bio Fluff System, a medical device designed for wound care or tissue integration applications. This product is intended for use in clinical settings where controlled tissue interaction or bioabsorption is required.
The Bio Fluff System is classified as a Class II device under regulatory frameworks and has been authorised through the FDA’s 510(k) pathway. The company is based in the United States, where its device is listed for commercial distribution.
Catalogue
Bio Fluff System Ref K201861
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gnali Bocia S.R.L. have in the registry?
The registry currently lists 1 device for Gnali Bocia S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gnali Bocia S.R.L.'s devices?
Among its 1 most recently registered device, Gnali Bocia S.R.L. has devices listed in FDA 510(k) (1 device).
What risk classes do Gnali Bocia S.R.L.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gnali Bocia S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gnali Bocia S.R.L. in the registry?
The most recently registered devices listed for Gnali Bocia S.R.L. include Bio Fluff System.