Carolina Medical Electronics
Country not established
- Devices
- 11
What Carolina Medical Electronics makes
Carolina Medical Electronics manufactures diagnostic ultrasound devices, including transcranial Doppler systems like the TC2-64B and Trans-Scan 3-D, as well as cardiac Doppler ultrasound models such as the Sonacolor CD and Sonacolor 6000. Their portfolio also includes vascular assessment tools like the Vascumap Medical Air Plethysmograph and electromagnetic blood flow systems such as the Cliniflow II. Additional products include Doppler ultrasound probes (e.g., DopScan Plus DS1060), nuclear medicine probes (e.g., Uptake Probe), and patient warming systems like the Patient Heater System (Model PH112).
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in the United States, where they must comply with U.S. medical device regulations.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Carolina Medical Electronics have in the registry?
The registry currently lists 11 devices for Carolina Medical Electronics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carolina Medical Electronics's devices?
Among its 11 most recently registered devices, Carolina Medical Electronics has devices listed in FDA 510(k) (11 devices).
What risk classes do Carolina Medical Electronics's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Carolina Medical Electronics's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Carolina Medical Electronics in the registry?
The most recently registered devices listed for Carolina Medical Electronics include TC2-64B TRANSCRANIAL DOPPLER, VASCUMAP MEDICAL AIR PLETHYSMOGRAPH, SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND and DOPSCAN PLUS DS1060.