Weipeng (Suzhou) Medical Devices Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3018884581
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Weipeng (Suzhou) Medical Devices Co., Ltd. makes
Weipeng (Suzhou) Medical Devices Co., Ltd. manufactures the AcuSee AS-P1000 System, a diagnostic imaging device designed for retinal imaging and analysis, supporting ophthalmic evaluations.
The company’s portfolio is regulated under Class II devices in the US, with the AcuSee AS-P1000 System listed via a 510(k) submission to the FDA. The manufacturer is based in the United States.
Catalogue
AcuSee AS-P1000 System Ref K202119
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3018884581
- Address
- 218 Xinghu St., Suzhou Jiangsu
Frequently asked questions
How many devices does Weipeng (Suzhou) Medical Devices Co., Ltd. have in the registry?
The registry currently lists 1 device for Weipeng (Suzhou) Medical Devices Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Weipeng (Suzhou) Medical Devices Co., Ltd.'s devices?
Among its 1 most recently registered device, Weipeng (Suzhou) Medical Devices Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Weipeng (Suzhou) Medical Devices Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Weipeng (Suzhou) Medical Devices Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Weipeng (Suzhou) Medical Devices Co., Ltd. in the registry?
The most recently registered devices listed for Weipeng (Suzhou) Medical Devices Co., Ltd. include AcuSee AS-P1000 System.