Regulatory Associates, Inc.
Country not established
- Devices
- 1
What Regulatory Associates, Inc. makes
Regulatory Associates, Inc. manufactures the RETINADX, a diagnostic device designed for retinal imaging and analysis, likely used in ophthalmology to assess retinal conditions.
The company’s portfolio is regulated under FDA Class II devices, with the RETINADX authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Retinadx Ref K003236
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Regulatory Associates, Inc. have in the registry?
The registry currently lists 1 device for Regulatory Associates, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regulatory Associates, Inc.'s devices?
Among its 1 most recently registered device, Regulatory Associates, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Regulatory Associates, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Regulatory Associates, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Regulatory Associates, Inc. in the registry?
The most recently registered devices listed for Regulatory Associates, Inc. include RETINADX.