Pacific Kangtai Completes Medical Device Master File Registration for Recombinant Superoxide Dismutase 

In-house developed rh-SOD raw material reaches a new regulatory milestone in China

JINAN, China — Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd. has completed the Medical Device Master File registration for its in-house developed Recombinant Superoxide Dismutase (rh-SOD) raw material in China.

The registered master file is identified as:

Medical Device Master File Registration No.: M2026252-000

The registration was completed through the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA).

This marks another important regulatory milestone for Pacific Kangtai’s medical raw material portfolio and further strengthens the documentation framework available for customers evaluating recombinant SOD in medical device development projects.

Recombinant Superoxide Dismutase is one of Pacific Kangtai’s key functional raw materials. The company continues to develop standardized raw material systems and supporting technical documentation to better serve medical device manufacturers, R&D teams and industry partners.

With the completion of the master file registration, Pacific Kangtai will continue to improve its regulatory, quality and technical support capabilities for downstream product development and registration projects.

For customers interested in evaluating recombinant SOD raw materials, the company can provide relevant product specifications, COA, technical documentation and project support according to specific requirements.

Medical Device Master File Registration No.: M2026252-000

Pacific Kangtai Scientific Instruments (Jinan) Co., Ltd.