Biomni Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Biomni Medical Systems, Inc. makes
Biomni Medical Systems, Inc. manufactures the BIO-BINKI, a device designed for breast imaging, and the SELECTACUT Biopsy Device, used for targeted tissue sampling in medical diagnostics.
The company’s portfolio includes Class II devices authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory records and are based in the United States.
Catalogue
Bio-Binki Ref K961782
Regimes: 510(k) Registry: 510(k)Selectacut Biopsy Device Ref K914215
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biomni Medical Systems, Inc. have in the registry?
The registry currently lists 2 devices for Biomni Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomni Medical Systems, Inc.'s devices?
Among its 2 most recently registered devices, Biomni Medical Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biomni Medical Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biomni Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomni Medical Systems, Inc. in the registry?
The most recently registered devices listed for Biomni Medical Systems, Inc. include BIO-BINKI and SELECTACUT BIOPSY DEVICE.