Great news! Focusfreda has successfully obtained the Master Document Registration for two Class III medical device raw materials, setting a new benchmark in the industry with its technological breakthroughs.
On March 18, 2025, the official website of the Center for Medical Device Technical Review of the National Medical Products Administration released the latest announcement, stating that the Class III medical device-grade sodium hyaluronate raw material (product model: SH-MDI) independently developed by Focusfreda has successfully passed the Master Document Registration certification (registration number: M2025052-000). This certification was obtained only two months after the company's another Class III medical device-grade sodium hyaluronate raw material (product model: SH-MDN) received the Master Document Registration qualification (registration number: M2025008-000) on January 17 this year, marking Focusfreda's dual technological breakthroughs in the field of high-end medical device raw materials.
The newly certified SH-MDI raw material features excellent production processes and product indicators, making it a high-end customized strategic product developed to meet customer needs. Previously certified SH-MDN, as the company's core raw material in the Class III medical device field, has been widely applied in the product systems of multiple key partners with its good biocompatibility and stability, forming a large-scale market application.
From the initial certification of SH-MDN in January to the secondary breakthrough of SH-MDI in March, Focusfreda has consecutively obtained two Master Document Registrations for Class III medical device raw materials within just two months, demonstrating the company's profound accumulation in the research and development of medical sodium hyaluronate raw materials.
Currently, Focusfreda implements a dual-track service system of "standardized products + customized solutions". By constructing a differentiated service matrix, the company precisely responds to customer needs. This strategic model ensures the quality foundation with standardized products and empowers personalized needs with customized research and development, forming a service ecosystem where standardization and customization develop synergistically. It aims to provide global customers with solutions that are both universal and exclusive.
Shandong Focusfreda Biotech Co., Ltd., a subsidiary of Lu Shang Freda Pharmaceutical Co., Ltd., is a national high-tech enterprise integrating research and development, production, and sales of sodium hyaluronate. Freda is the founder and leader of China's sodium hyaluronate industry. The company fully covers various types of sodium hyaluronate raw materials required by the pharmaceutical sector, achieving customized production for all types below 2.6 million Da, ensuring stable supply and meeting the diversified needs of global customers. Inquiries are welcome!
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