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Guangdong Zhizhen Biological Medical Co., Ltd.

ChinaFDA applicant, unverified

Devices
1

What Guangdong Zhizhen Biological Medical Co., Ltd. makes

Guangdong Zhizhen Biological Medical Co., Ltd. manufactures surgical masks designed for single-use in medical and healthcare settings to protect against airborne particles and pathogens.

The company’s products fall under FDA Class II devices and are listed via the 510(k) pathway in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Surgical Mask Ref K212997

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

Frequently asked questions

How many devices does Guangdong Zhizhen Biological Medical Co., Ltd. have in the registry?

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

Which registries list Guangdong Zhizhen Biological Medical Co., Ltd.'s devices?

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

What risk classes do Guangdong Zhizhen Biological Medical Co., Ltd.'s devices fall under?

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

What are the newest devices from Guangdong Zhizhen Biological Medical Co., Ltd. in the registry?

The most recently registered devices listed for Guangdong Zhizhen Biological Medical Co., Ltd. include Surgical Mask.

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