Consure Medical Pvt, Ltd.
Country not established
- Devices
- 2
What Consure Medical Pvt, Ltd. makes
Consure Medical Pvt., Ltd. manufactures stool management systems designed for patients with fecal incontinence, including disposable and reusable kits for bowel management. Their products include single-use and multi-use solutions tailored for different clinical needs, such as the CONSURE Stool Management System and the Qora series (AIM, Aeon, Arida). These devices are intended for use in both home and clinical settings to improve patient comfort and hygiene.
The company’s portfolio is classified under Class II medical devices in the U.S. and is listed in the FDA’s 510(k) registry, reflecting their regulatory pathway for clearance. Their products are intended for commercial distribution within the United States, adhering to U.S. medical device regulations.
Catalogue
Consure Stool Management System Ref K133465
Regimes: 510(k) Registry: 510(k)Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit Ref K153506
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Consure Medical Pvt, Ltd. have in the registry?
The registry currently lists 2 devices for Consure Medical Pvt, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Consure Medical Pvt, Ltd.'s devices?
Among its 2 most recently registered devices, Consure Medical Pvt, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Consure Medical Pvt, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Consure Medical Pvt, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Consure Medical Pvt, Ltd. in the registry?
The most recently registered devices listed for Consure Medical Pvt, Ltd. include CONSURE STOOL MANAGEMENT SYSTEM and Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit.