Shanghai Achieva Medical Suzhou Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3018070217
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shanghai Achieva Medical Suzhou Co., Ltd. makes
Shanghai Achieva Medical Suzhou Co., Ltd. manufactures the DCwire Micro-guidewire, a specialized guidewire designed for precise vascular navigation in interventional procedures.
The DCwire Micro-guidewire is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
DCwire Micro-guidewire Ref K252122
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3018070217
- DUNS number
- 551092746
- Address
- No.8 Zhongtian Alley, Suzhou Industrial Park,Suzhou Jiangsu, 215028, China, Suzhou Jiangsu
Frequently asked questions
How many devices does Shanghai Achieva Medical Suzhou Co., Ltd. have in the registry?
The registry currently lists 9 devices for Shanghai Achieva Medical Suzhou Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Achieva Medical Suzhou Co., Ltd.'s devices?
Among its 9 most recently registered devices, Shanghai Achieva Medical Suzhou Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shanghai Achieva Medical Suzhou Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Shanghai Achieva Medical Suzhou Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Achieva Medical Suzhou Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Achieva Medical Suzhou Co., Ltd. include DCwire™ FG62001022, DCwire™ FG62001023, DCwire™ FG62001412 and DCwire™ FG62001422.