Chang Gung Medical Supplies & Equipment Corp.
Country not established
- Devices
- 1
What Chang Gung Medical Supplies & Equipment Corp. makes
Chang Gung Medical Supplies & Equipment Corp. manufactures Doppler ultrasound systems designed for medical imaging, including curved linear array probes (2-5 MHz and 5-10 MHz), phased array probes (2-4 MHz), and transvaginal probes (4-8 MHz). These devices are intended for diagnostic imaging to assess blood flow and internal organ structures in clinical settings.
The company’s Doppler ultrasound systems fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance through the FDA. These devices are listed in the FDA’s 510(k) database, adhering to US medical device regulations. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chang Gung Medical Supplies & Equipment Corp. have in the registry?
The registry currently lists 1 device for Chang Gung Medical Supplies & Equipment Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chang Gung Medical Supplies & Equipment Corp.'s devices?
Among its 1 most recently registered device, Chang Gung Medical Supplies & Equipment Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Chang Gung Medical Supplies & Equipment Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Chang Gung Medical Supplies & Equipment Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chang Gung Medical Supplies & Equipment Corp. in the registry?
The most recently registered devices listed for Chang Gung Medical Supplies & Equipment Corp. include DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV.