QUALIFICATIONS

Compliance First, Credentials That Carry You

BORUI invests continuously in compliance — we hold medical device registrations, manufacturing and trading licenses, and dual ISO 9001 / ISO 13485 certification. As a Beijing Municipal Pharmaceutical Reserve Unit, we provide our customers with complete product admission and quality assurance documents.

20+
Medical Device Registrations
ISO
Quality Management Certifications
High-Tech
Enterprise Certificate
Municipal
Pharmaceutical Reserve Unit

Licenses & Certifications

Business License
Beijing Municipal Administration for Market Regulation

Business License

Unified Social Credit Code: 91110109700299269E

Medical Device Manufacturing License
Beijing Medical Products Administration

Medical Device Manufacturing License

Authorized to manufacture medical devices across protective, gauze, cotton products and non-woven series.

Medical Device Trading License
Beijing Medical Products Administration

Medical Device Trading License

Legally licensed to trade Class II and Class III medical devices.

High-Tech Enterprise Certificate
Ministry of Science and Technology / Ministry of Finance / State Taxation Administration

High-Tech Enterprise Certificate

Holder of the High-Tech Enterprise Certificate.

ISO 9001:2015 Quality Management System Certification
Beijing Guocheng Huaguang Certification Co., Ltd.

ISO 9001:2015 Quality Management System Certification

Covers the R&D, manufacturing, and sales of medical bandages, gauze, masks, protective suits, and the entire product portfolio.

ISO 13485:2016 Medical Device Quality Management System Certification
Beijing Guocheng Huaguang Certification Co., Ltd.

ISO 13485:2016 Medical Device Quality Management System Certification

Meets international medical device quality management system requirements, ensuring end-to-end quality control from raw materials to factory release.

Innovation & Social Recognition

Beijing SME Top 100 Private Enterprises (Ranked 58th, 2020)
Beijing Federation of Industry and Commerce

Beijing SME Top 100 Private Enterprises (Ranked 58th, 2020)

Listed among Beijing's Top 100 SME private enterprises, recognized for combined social and economic strength.

National Quality-Trusted Product (Featured Promotion Unit)
China Light Industry Product Quality Assurance Center

National Quality-Trusted Product (Featured Promotion Unit)

BORUI brand medical protective gear, sanitary materials, and dressing products awarded the Center's "Quality-Trusted Product" certificate.

Aid in Times of Hardship · Devotion of Care
Beijing Shunyi District Disaster Relief Donation Management Center

Aid in Times of Hardship · Devotion of Care

Active participant in social donations and outreach to disaster-affected and impoverished communities, carrying forward the Chinese tradition of aid and compassion.

BORUI · Mask performance testing equipment

Continuous Compliance, Behind Every Product

From raw materials to finished goods, BORUI follows ISO 13485 medical device quality management — covering R&D design, manufacturing and release with end-to-end quality controls. We can provide product registrations, test reports, manufacturing licenses, quality agreements, SDS and other compliance documents on request.