Diasia Biomedical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000010281
- Devices
- 79
- Registrations
- EUDAMED
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.
Catalogue
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Company details
- EUDAMED SRN
- CN-MF-000010281
- EUDAMED status
- Active
- EUDAMED registered name
- Diasia Biomedical Technology Co., Ltd.
- EUDAMED abbreviated name
- Diasia
- Registered address
- No.62 Nanchang Road, Nanchang Community, Xixiang Subdistrict, 518102, ShenZhen, China
- Website
- en.diasia.com.cn
- [email protected]
- Phone
- +86 13267096505
- PRRC contact
- May Xiao
From the company website
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.