Bright Uro, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 3029753827
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Bright Uro, Inc. makes
Bright Uro, Inc. manufactures urodynamic assessment systems, including male and female delivery systems for diagnostic testing, a uroflowmeter for measuring urine flow rates, and an abdominal pressure sensor for bladder function evaluation.
The company’s portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. These devices are listed under the FDA’s regulatory records and are based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- 510(k) 510(k)
- 510(k) 510(k)
Company details
- FDA FEI number
- 3029753827
- DUNS number
- 117955543
- Address
- 3 Goddard, Irvine, CA, 92618
Frequently asked questions
How many devices does Bright Uro, Inc. have in the registry?
The registry currently lists 10 devices for Bright Uro, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bright Uro, Inc.'s devices?
Among its 10 most recently registered devices, Bright Uro, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bright Uro, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Bright Uro, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bright Uro, Inc. in the registry?
The most recently registered devices listed for Bright Uro, Inc. include Glean GUS-1000-F, Glean GUS-1000-M, Glean UFM-1000 and Glean UFM-1000-CP.