With rising public awareness of health management, household in vitro diagnostic devices have become an essential tool for daily at-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 compliant operation 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 production and operation qualifications for medical devices, and conducts all production procedures in compliance with the Regulations on the Supervision and Administration of Medical Devices. Multiple quality control checks are implemented throughout the workflow, from raw material warehousing and component processing to product assembly and factory inspection. Only upstream suppliers meeting national medical device standards are selected for raw materials, and complete quality inspection reports are attached to every batch of test strips and core instrument parts. Its production workshops maintain a Class 100,000 cleanroom environment. All staff hold valid work certificates and follow strict protocols including clean uniform wearing, hand sanitization and zone-specific operations to eliminate contamination risks during production.

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

Upholding the business philosophy of "Compliance First, Quality Oriented", the company actively participates in local medical device industry exchanges, cooperates with market regulatory authorities in compliance self-inspections, and constantly optimizes its internal quality control system. Moving forward, Hailais will ramp up 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, stable and affordable household medical device brand, helping the public develop scientific and regular at-home health monitoring routines.