Suzhou Hengrui Disheng Medical Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 3
What Suzhou Hengrui Disheng Medical Co., Ltd. makes
Suzhou Hengrui Disheng Medical Co., Ltd. manufactures vascular interventional devices, including microcatheter and guide-wire systems for precise delivery in angiographic procedures, as well as hydrophilic-coated guide wires for improved navigability. Their portfolio also includes angiographic catheters designed for contrast injection and imaging during coronary and peripheral interventions.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, reflecting compliance with US medical device regulations. The manufacturer operates from the United States.
Catalogue
Microcatheter and guide-wire system Ref K171665
Regimes: 510(k) Registry: 510(k)Hydrophilic Coating Guide Wire Ref K193653
Regimes: 510(k) Registry: 510(k)Superpipe Angiographic Catheter Ref K193647
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Suzhou Hengrui Disheng Medical Co., Ltd. have in the registry?
The registry currently lists 3 devices for Suzhou Hengrui Disheng Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Hengrui Disheng Medical Co., Ltd.'s devices?
Among its 3 most recently registered devices, Suzhou Hengrui Disheng Medical Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Suzhou Hengrui Disheng Medical Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Suzhou Hengrui Disheng Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Hengrui Disheng Medical Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Hengrui Disheng Medical Co., Ltd. include Microcatheter and guide-wire system, Hydrophilic Coating Guide Wire and Superpipe Angiographic Catheter.