Sunwell Biotech Co., Ltd.
Country not established
- Devices
- 1
What Sunwell Biotech Co., Ltd. makes
Sunwell Biotech Co., Ltd. manufactures auto-disable sterile safety syringes designed for single-use medical applications. These syringes incorporate safety features to reduce needle-stick injuries during use and disposal.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Auto-Disable Sterile Safty Syring For Single Use Ref K121637
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sunwell Biotech Co., Ltd. have in the registry?
The registry currently lists 1 device for Sunwell Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sunwell Biotech Co., Ltd.'s devices?
Among its 1 most recently registered device, Sunwell Biotech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sunwell Biotech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sunwell Biotech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sunwell Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Sunwell Biotech Co., Ltd. include AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE.