Matria Healthcare, Inc.
Country not established
- Devices
- 3
What Matria Healthcare, Inc. makes
Matria Healthcare, Inc. manufactures home uterine activity monitoring systems, including the CareFone™ Home Uterine Activity Monitor System, the Genesis Home Uterine Activity Monitoring System (HUAM), and the System 37 Home Uterine Activity Monitoring System. These devices are designed to track fetal heart rate and uterine contractions in an outpatient setting, enabling remote monitoring for pregnant patients.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s Premarket Approval (PMA) pathway. These devices are listed in the FDA’s registry under PMA authorisations and are intended for use in the United States.
Catalogue
Carefone(Tm)Home Uterine Activity Monitor System Ref P910063
Regimes: PMA Registry: PMA- Regimes: PMA Registry: PMA
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Matria Healthcare, Inc. have in the registry?
The registry currently lists 3 devices for Matria Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Matria Healthcare, Inc.'s devices?
Among its 3 most recently registered devices, Matria Healthcare, Inc. has devices listed in FDA PMA (3 devices).
What risk classes do Matria Healthcare, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Matria Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Matria Healthcare, Inc. in the registry?
The most recently registered devices listed for Matria Healthcare, Inc. include CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM, GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM) and SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM.