Zhongshan Xiaolan Town Senlan Electronic Factory
ChinaFDA applicant, unverified FDA FEI 3016587556
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Zhongshan Xiaolan Town Senlan Electronic Factory makes
The company manufactures fetal Doppler devices, including models U8-25 and U9-25, designed for non-invasive prenatal monitoring of fetal heart rate.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Fetal Doppler U8-25, U9-25 Ref K252669
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3016587556
- Address
- 2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town, Zhongshan City Guangdong
Frequently asked questions
How many devices does Zhongshan Xiaolan Town Senlan Electronic Factory have in the registry?
The registry currently lists 1 device for Zhongshan Xiaolan Town Senlan Electronic Factory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhongshan Xiaolan Town Senlan Electronic Factory's devices?
Among its 1 most recently registered device, Zhongshan Xiaolan Town Senlan Electronic Factory has devices listed in FDA 510(k) (1 device).
What risk classes do Zhongshan Xiaolan Town Senlan Electronic Factory's devices fall under?
Among its 1 most recently registered device, the classes recorded for Zhongshan Xiaolan Town Senlan Electronic Factory's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zhongshan Xiaolan Town Senlan Electronic Factory in the registry?
The most recently registered devices listed for Zhongshan Xiaolan Town Senlan Electronic Factory include Fetal Doppler U8-25, U9-25.