Company History

Awarded the prestigious "SRDI (Specialized, Refined, Differential, Innovative) Enterprise" and "Innovative SME" titles, validating our cutting-edge R&D capabilities and enduring leadership in the global IVD sector.

Officially certified as a Provincial High-Tech R&D Center and designated an "Industrial Leading Enterprise." Our advanced hair drug testing kits were exclusively shortlisted in the Ministry of Public Security's central procurement directory.

Achieved major global penetration with products distributed across 40+ countries. The "LYHER®" brand secured trademark registrations in 18 strategic markets, including the EU, USA, Brazil, and Japan.

Successfully passed the rigorous Ministry of Public Security evaluation for hair drug detection. Secured a robust intellectual property portfolio comprising 8 international invention patents, 10 design patents, and 5 software copyrights.

Spearheaded pandemic response efforts with over 100,000 test kit donations globally. Attained premier international regulatory approvals, including US FDA EUA, German BfArM, and French ANSM.

Honored as an "AAA-Level Quality-Oriented and Trustworthy Enterprise," reflecting our uncompromising commitment to strict quality control systems and ethical, transparent business practices.

Successfully registered and launched 6 Class III medical devices. Laihe was officially honored with the "National High-Tech Enterprise" certification, a testament to our continuous technological innovation.

Awarded seven pivotal patents for diagnostic technologies. Our premier Drugs of Abuse (DOA) rapid tests were formally shortlisted in the Ministry of Public Security’s recommended anti-drug catalog.

Cleared rigorous ISO 13485 and CE compliance standards, marking the official launch of our global export operations and bringing high-fidelity diagnostic solutions to international markets.

Hangzhou Laihe Biotech Co., Ltd. was established, immediately winning the prestigious "Hangzhou 5050 Overseas High-Level Talents" support project. Successfully obtained our core Medical Device Production License.