Gabriel Ent.
Country not established
- Devices
- 2
What Gabriel Ent. makes
Gabriel Ent. manufactures digital electrocardiogram (ECG) monitoring systems, including the Gabriel Digitrend for continuous cardiac rhythm recording and the Trendoscope for real-time ECG waveform display and analysis. These devices are designed for clinical and ambulatory use to capture and analyze heart activity for diagnostic purposes.
The company’s products fall under FDA Class II regulatory classification and are listed via 510(k) clearance. The portfolio is regulated under U.S. medical device laws, with no additional international registries specified.
Catalogue
Gabriel Digitrend Ref K822795
Regimes: 510(k) Registry: 510(k)Trendo-Scope Ref K831995
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gabriel Ent. have in the registry?
The registry currently lists 2 devices for Gabriel Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gabriel Ent.'s devices?
Among its 2 most recently registered devices, Gabriel Ent. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gabriel Ent.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gabriel Ent.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gabriel Ent. in the registry?
The most recently registered devices listed for Gabriel Ent. include GABRIEL DIGITREND and TRENDO-SCOPE.