Datamedix
Country not established
- Devices
- 2
What Datamedix makes
Datamedix manufactures the PECGASys System, a medical device designed for fetal and maternal cardiac monitoring, including remote transmission capabilities for continuous or intermittent monitoring during pregnancy. The system includes hardware for real-time ECG and fetal heart rate data acquisition, alongside software for data analysis and transmission to healthcare providers.
The company’s portfolio is regulated as Class II devices under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Datamedix Pecgasys System Ref K810027
Regimes: 510(k) Registry: 510(k)Pecgasys Remote Transmission Unit Ref K831092
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Datamedix have in the registry?
The registry currently lists 2 devices for Datamedix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datamedix's devices?
Among its 2 most recently registered devices, Datamedix has devices listed in FDA 510(k) (2 devices).
What risk classes do Datamedix's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Datamedix's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datamedix in the registry?
The most recently registered devices listed for Datamedix include DATAMEDIX PECGASYS SYSTEM and PECGASYS REMOTE TRANSMISSION UNIT.