Hangzhou Lifereal Biotechnology Co., Ltd

Hangzhou Lifereal Biotechnology Co., Ltd specializes in laboratory systems for nucleic acid analysis. Their devices include automated platforms like the Automatic Integrated Gene Detection System, Real-Time Fluorescence Quantitative PCR systems, and Nucleic Acid Extraction Systems. These tools are primarily used for high-throughput molecular diagnostics and research, supporting tasks such as DNA/RNA extraction, amplification, and detection in clinical or research environments.

The company is headquartered in China, specifically in Hangzhou. This location reflects its focus on developing and manufacturing nucleic acid analysis systems tailored for global markets, including Europe.

Hangzhou Lifereal Biotechnology Co., Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion indicates compliance with EU regulatory requirements for medical devices, though individual device authorisation depends on specific regulatory pathways.

The company’s devices fall under EU Class A classification. This classification is typically assigned to low-risk medical devices, such as nucleic acid analysis systems, where the risk to patient health is minimal. Classification is determined by factors like intended use, duration of use, and potential risks, as outlined in EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

Buyers should verify the regulatory status because individual devices—not the manufacturer—must meet specific authorisation requirements (e.g., CE marking under EU MDR/IVDR) to legally enter markets like the EU. While the company’s devices are listed in EUDAMED, compliance with local regulations (e.g., FDA, ISO standards) depends on the destination market and device classification. Always confirm the device’s intended use and applicable certifications before procurement.