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Sunray Medical Apparatus Co., Ltd.

ChinaFDA applicant, unverified

Devices
1

What Sunray Medical Apparatus Co., Ltd. makes

Sunray Medical Apparatus Co., Ltd. manufactures the SUNRAY FETAL MONITOR, a device used for real-time monitoring of fetal heart rate and uterine contractions during pregnancy.

The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Sunray Fetal Monitor Ref K123335

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Sunray Medical Apparatus Co., Ltd. have in the registry?

The registry currently lists 1 device for Sunray Medical Apparatus Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sunray Medical Apparatus Co., Ltd.'s devices?

Among its 1 most recently registered device, Sunray Medical Apparatus Co., Ltd. has devices listed in FDA 510(k) (1 device).

What risk classes do Sunray Medical Apparatus Co., Ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Sunray Medical Apparatus Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Sunray Medical Apparatus Co., Ltd. in the registry?

The most recently registered devices listed for Sunray Medical Apparatus Co., Ltd. include SUNRAY FETAL MONITOR.

Generated automatically from registry data and not verified by a human reviewer.