Biocare Intl.
Country not established
- Devices
- 1
What Biocare Intl. makes
Biocare International manufactures the BCI-100 Fecal Incontinence System, a device designed to manage and reduce episodes of fecal incontinence in patients.
The BCI-100 is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Bci-100 Fecal Incontinence System Ref K904646
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocare Intl. have in the registry?
The registry currently lists 1 device for Biocare Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocare Intl.'s devices?
Among its 1 most recently registered device, Biocare Intl. has devices listed in FDA 510(k) (1 device).
What risk classes do Biocare Intl.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biocare Intl.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocare Intl. in the registry?
The most recently registered devices listed for Biocare Intl. include BCI-100 FECAL INCONTINENCE SYSTEM.