General Devices
Country not established
- Devices
- 23
What General Devices makes
General Devices manufactures diagnostic and monitoring devices, including ECG systems like the GEMSCOM Series 3000, 5000, and 6000 (with models 6100, 6200, and 6300), as well as 12-lead ECG options for the Series 300. Their portfolio also includes telemetry solutions like the TRU-VIEW Multi-Channel Display and telemedicine options for the GEMSCOM Series 4000. Additional products include portable ECG devices such as the PREP-CHECK, EIM-107 PREP-CHECK, and DR-2C, along with modified versions like the MODIFIED DR-2C/PMC 100. The company also produces patient monitoring tools like the AP-CHECK and ROSETTA-LT/ROSETTA-RX.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory records supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. General Devices operates from the United States.
Catalogue
Search and filter all 23 devicesCompany details
- DUNS number
- 101394815
Frequently asked questions
How many devices does General Devices have in the registry?
The registry currently lists 23 devices for General Devices. Devices recorded under merged duplicate company entries are counted once.
Which registries list General Devices's devices?
Among its 23 most recently registered devices, General Devices has devices listed in FDA 510(k) (13 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do General Devices's devices fall under?
Among its 23 most recently registered devices, the classes recorded for General Devices's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from General Devices in the registry?
The most recently registered devices listed for General Devices include GD Prep-Check Plus, 20 pin, GD Prep-Check 30Hz, GD Prep-Check Plus, 25 pin and GD Prep-Check Plus, 37 pin.