Iren-Medical, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Iren-Medical, Ltd. makes
Iren-Medical, Ltd. manufactures the Intelligent Dialysis Assistant (IDA), a digital system for dialysis clinics that integrates with a medical supervision portal and a smartphone app to support dialysis management.
The IDA is classified as a Class II medical device in the US and is listed under FDA 510(k) premarket notification requirements. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iren-Medical, Ltd. have in the registry?
The registry currently lists 1 device for Iren-Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iren-Medical, Ltd.'s devices?
Among its 1 most recently registered device, Iren-Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Iren-Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Iren-Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iren-Medical, Ltd. in the registry?
The most recently registered devices listed for Iren-Medical, Ltd. include Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App.