Singclean Medical Achieves EU MDR CE Certification for Medical Sodium Hyaluronate Gel

Discover Singclean Medical's MDR CE-certified sodium hyaluronate injection for bone joint, supporting global demand for hyaluronic knee injection and viscosupplementation.

HANGZHOU, China – September 2026 – Singclean Medical has reached a major milestone in its international development of orthopedic medical devices with the successful acquisition of CE certification under EU Medical Device Regulation (MDR) 2017/745 for its Medical Sodium Hyaluronate Gel for Bone Joint.

The certification marks an important step forward for Singclean Medical's orthopedic product portfolio and further demonstrates the company's commitment to meeting stringent international regulatory and quality requirements.

The CE certificate was presented in person by Ms. Eftang, Cathrine Norstad, Head of Clinical Review at DNV Headquarters, to Mr. Sun Weiqing, General Manager of Singclean Medical, representing a significant moment in Singclean Medical's continued expansion into regulated international markets.

The newly obtained certification carries particular significance within the field of hyaluronic acid-based orthopedic products.

According to Singclean Medical, this is the first MDR CE certificate for hyaluronic acid-based orthopedic products issued by DNV worldwide. Singclean Medical is also the first Chinese company to obtain such certification in this category and ranks among the first three companies globally to secure a viscosupplementation MDR CE certificate.

These achievements highlight the company's capabilities in developing and commercializing orthopedic biomaterial products that meet demanding international regulatory standards.

As interest in non-surgical approaches to joint care continues to grow, sodium hyaluronate-based viscosupplementation remains an important area within orthopedic healthcare. CE certification under the MDR provides an important regulatory milestone for manufacturers serving healthcare providers and medical device distributors across Europe.

Obtaining certification under EU MDR 2017/745 requires medical device manufacturers to demonstrate compliance across a broad range of technical, clinical, quality, and post-market requirements.

During the certification process, Singclean Medical underwent a comprehensive assessment covering areas including technical documentation, clinical evaluation, risk management, quality management, and post-market surveillance.

The successful completion of this process reflects Singclean Medical's integrated capabilities in medical device R&D, clinical evaluation, quality assurance, regulatory affairs, and international market compliance.

It also demonstrates the rigorous assessment conducted by DNV, an internationally recognized notified body with certification activities covering both the MDR and IVDR regulatory frameworks.

The certified Medical Sodium Hyaluronate Gel for Bone Joint strengthens Singclean Medical's offering for international orthopedic markets and provides an additional option for distributors and healthcare partners seeking CE-certified hyaluronic acid-based medical devices.

Sodium hyaluronate is widely used in viscosupplementation products developed for joint-related applications. In clinical practice, a hyaluronic knee injection may be considered by qualified healthcare professionals as part of an individualized approach to managing knee osteoarthritis and related joint symptoms.

For distributors, importers, and healthcare organizations, the new MDR CE certification further enhances the international market potential of Singclean Medical's sodium hyaluronate injection products.

Beyond the certification of a single product, the achievement represents Singclean Medical's broader investment in international regulatory compliance and quality management.

By continuously aligning its product development and manufacturing processes with international regulatory requirements, Singclean Medical aims to provide medical device partners with products supported by robust quality systems and internationally recognized certifications.

The MDR CE certification also reinforces the company's ability to serve the European orthopedic market and pursue further opportunities in other regulated healthcare markets.

Singclean Medical will continue to strengthen its collaboration with DNV and other internationally recognized certification bodies while investing in the development of innovative medical devices and biomaterial solutions.

The company will also continue working with global distributors and healthcare partners to expand access to high-quality orthopedic products, including sodium hyaluronate injection and viscosupplementation solutions.

With this latest EU MDR CE certification, Singclean Medical takes another important step in its international development and reinforces its commitment to bringing high-quality Chinese medical devices to healthcare markets around the world.