With growing public awareness of health management, household in vitro diagnostic devices have become an essential tool for daily home health monitoring. Rooted in Dandong, Hailais Biotechnology (Dandong) Co., Ltd. specializes in the R&D, production and one-stop services of household blood glucose monitoring medical devices. Adhering to compliance standards over the years, the company delivers stable and reliable home monitoring products through standardized manufacturing and continuous technological upgrades.

The enterprise holds a full set of qualifications for medical device production and operation. All manufacturing procedures comply with the Regulations on the Supervision and Administration of Medical Devices, with multi-layer quality control implemented throughout raw material warehousing, component processing, finished product assembly and factory inspection. It sources upstream suppliers meeting national medical device standards; every batch of test strips and core instrument components comes with complete quality inspection reports. Production workshops maintain Class 100,000 cleanroom standards. All staff hold valid work certificates and follow strict protocols including clean uniform wear, hand sanitization and zoned operation to eliminate production contamination risks.

Hailais has built a full-spectrum supporting service system for distributors, medical institutions and retail partners. It provides collaborators with qualification documents, compliance materials, warehouse storage guidance and after-sales troubleshooting training. For end users, online and offline consultation channels are available to address inquiries about device operation, storage and maintenance, guiding standardized use in line with product manuals.

Upholding the business philosophy of "Compliance First, Quality Oriented", the company actively participates in local medical device industry exchanges, cooperates with market supervision authorities on compliance self-inspections, and continuously optimizes internal quality control systems. Moving forward, Hailais will boost R&D investment to further explore the household in vitro monitoring sector. Leveraging Dandong’s local industrial supporting advantages, it aims to build a standardized, dependable and affordable home medical device brand, empowering the public to develop scientific, regular at-home health monitoring routines.