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Sign in to claim this brandChang Gung Medical Technology Co., Ltd.
US
Last updated May 23, 2026
What Chang Gung Medical Technology Co., Ltd. makes
Chang Gung Medical Technology Co., Ltd. manufactures diagnostic ultrasound systems, including the OPUS 5100 Diagnostic Doppler Ultrasound System, and dental implant components as part of the Chang Gung ComMed Series. These products are designed for vascular imaging and osseointegrated dental restoration applications, respectively.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Chang Gung Medical Technology Co., Ltd. manufacture?
Chang Gung Medical Technology Co., Ltd. produces diagnostic ultrasound systems, such as the OPUS 5100 Diagnostic Doppler Ultrasound System, which are used for vascular imaging. They also manufacture dental implant components as part of the Chang Gung ComMed Series, designed for osseointegrated dental restoration.
Where is Chang Gung Medical Technology Co., Ltd. based?
The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and listing of its devices.
Which regulatory registries list Chang Gung Medical Technology Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices, which require a premarket notification submission to demonstrate substantial equivalence to a legally marketed predicate device.
How are Chang Gung Medical Technology Co., Ltd.’s devices classified under FDA regulations?
The company’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as 510(k) clearance to demonstrate equivalence to an existing predicate.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OPUS 5100 Diagnostic Doppler Ultrasound System | K142982 | FDA 510(k) | Class II | Active |
| Opus Diagnostic Ultrasound System & Transducers | K102989 | FDA 510(k) | Class II | Active |
| Chang Gung ComMed Series Dental Implant System | K142751 | FDA 510(k) | Class II | Active |
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