Comprehensive IVD Solutions for Infectious Disease Detection
In vitro diagnostic (IVD) products for infectious disease, tropical disease and point-of-care testing, supplied to laboratory and distribution partners worldwide. Our EU regulatory pathway is confirmed by Notified Body TÜV Rheinland (NB 0197) under Regulation (EU) 2024/1860.
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E-mail: xx_hz@hotmail.com
For professional in-vitro diagnostic use only.
EU Regulatory Pathway
165 devices are listed in our Notified Body confirmation letter (TÜV Rheinland LGA Products GmbH, NB 0197, dated 2026-07-10): 88 Class C devices with transition to 2028-12-31 and 77 Class B devices with transition to 2029-12-31 under Regulation (EU) 2024/1860.
The confirmation letter records the IVDR application and the signed written agreement. It is not an IVDR certificate, a CE certificate or an EU Declaration of Conformity.
Multi-platform Technology
Isothermal amplification combined with CRISPR-based detection, lateral flow immunoassay, and multiplex fluorescent PCR — covering pathogen nucleic acid detection and rapid antigen/antibody testing.
International Distribution
We work with distribution and laboratory partners across Europe, the Middle East, Africa, Southeast Asia and Latin America. Regional availability, registration status and lead times are confirmed per order.
About Us
Kangsheng Yanxuan is the brand of Kangsheng Information Technology (Hangzhou) Co., Ltd. (EU SRN: CN-MF-000053775), an in vitro diagnostics company established in 2020 and based in Hangzhou, Zhejiang, P.R. China. Our production site is equipped with Class-100,000 cleanroom laboratories and supports an annual capacity of up to 10 million test units. Production quality is controlled under ISO 13485 and ISO 9001 quality management systems.
Legal manufacturer and product registration
Product registration and conformity documentation are held under Kangsheng Information Technology (Hangzhou) Co., Ltd., Room 2017, Building 1, No.5 Shengyi Road, Yuhang District, Hangzhou 310000, Zhejiang, P.R. China (EU SRN: CN-MF-000053775) — the legal manufacturer identified in our EU documentation. The trade name "Kangsheng Yanxuan" is a brand and is not a separate legal entity.
Our EU documentation consists of a Notified Body confirmation letter (TÜV Rheinland, NB 0197, 2026-07-10) covering 165 listed devices under Regulation (EU) 2024/1860. No IVDR certificate or CE certificate has been issued for these devices; further conformity assessment steps remain outstanding.
Production facilities
Our production site is GMP-compliant and equipped with Class-100,000 cleanroom laboratory areas, supporting an annual capacity of up to 10 million test units. Production quality is controlled under ISO 13485 and ISO 9001 quality management systems.
Images on this website are royalty-free stock photographs or schematic illustrations used for general illustration; they are not photographs of the site described above. Certification documents, capacity statements and audit references are available to qualified partners on request through our quality and regulatory contact route.
Product Portfolio
Our portfolio covers 165 devices across 14 market series, from pathogen nucleic acid detection to rapid lateral flow immunoassay. Browse the portfolio for category-level device lists, identifiers and regulatory classification.
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Production & Laboratory
Important information
This website is for informational purposes. All products are for professional in-vitro diagnostic use and are not intended for self-testing. Intended use, performance data and specifications are as stated in the Instructions for Use (IFU) and the applicable conformity documentation. Products are subject to regulatory approval in each market; availability may vary by country.
The content of this website is provided for corporate and product information purposes only. It does not constitute an offer, quotation, warranty or medical advice. The terms of the executed sales contract shall prevail.