Suzhou Hengrui Callisyn Biomedical Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Suzhou Hengrui Callisyn Biomedical Co., Ltd. makes
Suzhou Hengrui Callisyn Biomedical Co., Ltd. manufactures embolization microspheres, including the CalliSpheres and 8Spheres Embolic Microspheres, used for vascular occlusion in interventional radiology procedures.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Suzhou Hengrui Callisyn Biomedical Co., Ltd. have in the registry?
The registry currently lists 1 device for Suzhou Hengrui Callisyn Biomedical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Hengrui Callisyn Biomedical Co., Ltd.'s devices?
Among its 1 most recently registered device, Suzhou Hengrui Callisyn Biomedical Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Suzhou Hengrui Callisyn Biomedical Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Suzhou Hengrui Callisyn Biomedical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Hengrui Callisyn Biomedical Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Hengrui Callisyn Biomedical Co., Ltd. include CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres.