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Diasia Biomedical Technology Co., Ltd.

China CN-MF-000010281 Last updated 21 Oct 2026

Devices
79
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue79

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About

Shenzhen DIASIA Biomedical Technology Co., Ltd. was founded in 2013. The company has been deeply involved in research and develop the IVD instruments and reagents for many years, in the areas for PCR technology, hematology analysis, clinical chemistry, immunofluorescence, pathological staining, rapid tests, Diasia has been constructing its medical products system, particularly developed the variety POC machines and built the self-developed intelligent medical data management system. Diasia will continue to develop the technique and skills, at the same time provides better service for global partners. Diasia, as a Chinese enterprise who has a sense of mission, has been committing itslef to raise the ceiling on human health unremittingly, and will continue to work for it.

From the manufacturer's own website. Source

What Diasia Biomedical Technology Co., Ltd. makes

Diasia Biomedical Technology Co., Ltd. manufactures diagnostic test kits and instruments, including fluorescence-based immunoassays for ferritin and follicle-stimulating hormone, rapid lateral-flow tests for renal and blood donation screening, and freeze-dried multiplex PCR kits for HPV high-risk genotyping. Their portfolio also includes disposable medical masks, real-time PCR systems, urine analyzers, and point-of-care devices for blood lipid, glucose, and liver function monitoring.

The company’s products are classified under Class A and Class II regulatory categories, with in vitro diagnostic (IVD) reagents listed in the EU’s eudamed registry and subject to FDA’s 510(k) clearance process. The manufacturer is based in China and operates within global regulatory frameworks for medical devices and diagnostics.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
China(from SRN)
Address
No.62 Nanchang Road, Nanchang Community, Xixiang Subdistrict, ShenZhen, China
Phone
+86 13267096505
PRRC contact
May Xiao
EUDAMED SRN
CN-MF-000010281