Recently, our affiliated enterprise (Shen's Biomedical Technology (Huizhou) Co., Ltd.) has been strictly reviewed by the drug supervision and management department and successfully approved for the production record certificate of Class I medical devices, marking a crucial step forward in our independent research and development and standardized production of medical devices.

The Leap from "Design" to "Implementation"

The approval of the filing for Class I medical devices signifies that our company's related products have obtained formal production qualifications and can legally enter the market. Behind this achievement lies months of cross-departmental collaboration across R&D, quality, and production teams—from defining product classifications and drafting technical requirements to conducting on-site production verification and establishing a quality management system. Every step strictly adheres to regulatory standards, ultimately passing the filing review with zero defects.

Not just a certificate

Proof of Capability: Behind the filing certificate lies a complete supply chain and a reliable quality control system, which will serve as the "key" for us to secure larger orders and expand our medical device business.

Customer Trust: For downstream partners, this signifies our robust capability in compliant production, ensuring stable delivery of medical or household-grade device products that meet clinical or consumer requirements.

Business Scope: With the first production filing approved, the company can swiftly initiate filings and registrations for more categories of medical devices, advancing toward a "product matrix" model.

Gratitude and Outlook

Here, we would like to express our sincere gratitude to all the project team members for their dedicated efforts, as well as the trust from our partners and clients. Moving forward, we will continue to increase our investment in the healthcare sector, accelerate the transition and sales of our existing product lineup, and bring our rigorous medical-grade quality to more users.

Compliance is the bottom line, and innovation is the upper limit. We have only just begun.