E.B.S., Inc.
CanadaFDA 510(k) applicant, unverified
- Devices
- 3
What E.B.S., Inc. makes
E.B.S., Inc. manufactures the BIOMA 5000, BIOMA 3500, and BIOMA 2000 series of medical devices, which appear to be blood processing or filtration systems designed for clinical or laboratory use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Bioma 5000 Ref K880036
510(k) 510(k)Bioma 3500 Ref K872370
510(k) 510(k)Bioma 2000 Ref K862808
510(k) 510(k)
Frequently asked questions
How many devices does E.B.S., Inc. have in the registry?
The registry currently lists 3 devices for E.B.S., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list E.B.S., Inc.'s devices?
Among its 3 most recently registered devices, E.B.S., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do E.B.S., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for E.B.S., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from E.B.S., Inc. in the registry?
The most recently registered devices listed for E.B.S., Inc. include BIOMA 5000, BIOMA 3500 and BIOMA 2000.