Wondfo Biotech
Publicly traded Chinese manufacturer of rapid point-of-care diagnostic tests.
Updated Jul 1, 2026
Headquartered in China
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Overview
About Wondfo Biotech
Wondfo Biotech manufactures rapid point-of-care diagnostic tests and immunoassay testing systems, and is publicly traded, headquartered in Guangzhou, China.
Products
- Rapid point-of-care diagnostic tests
- Immunoassay testing systems
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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NMPA
China's medical device registration system, among the most demanding globally for higher-risk devices.
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Related
Regulatory Pathways
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