Cathegenix (Xiamen) Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 2
What Cathegenix (Xiamen) Co., Ltd. makes
Cathegenix (Xiamen) Co., Ltd. manufactures ureteral access sheaths, such as the Lumena™ Ureteral Access Sheath, and ureteral stents, including the Endura™ Ureteral Stent and its associated stent sets. These products are designed for use in urological procedures to facilitate access and drainage within the urinary tract.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for commercial distribution in the United States.
Catalogue
LumenaTM Ureteral Access Sheath Ref K250585
Regimes: 510(k) Registry: 510(k)Endura™ Ureteral Stent and Stent Set Ref K251469
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cathegenix (Xiamen) Co., Ltd. have in the registry?
The registry currently lists 2 devices for Cathegenix (Xiamen) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cathegenix (Xiamen) Co., Ltd.'s devices?
Among its 2 most recently registered devices, Cathegenix (Xiamen) Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cathegenix (Xiamen) Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cathegenix (Xiamen) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cathegenix (Xiamen) Co., Ltd. in the registry?
The most recently registered devices listed for Cathegenix (Xiamen) Co., Ltd. include LumenaTM Ureteral Access Sheath and Endura™ Ureteral Stent and Stent Set.