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Tigermed-Jyton Supports China NMPA Approval of STMed's Single-use Membrane Oxygenator Kit

On August 25, the single-use membrane oxygenator kit independently developed by Jiangsu STMed Technology Co., Ltd. (hereinafter referred to as " STMed ") was approved by the China National Medical Products Administration (NMPA) for marketing. As the CRO partner of this product, Tigermed-Jyton provides clinical trials and registration services with its deep accumulation in the full life cycle service field of medical devices for the successful marketing of the product.

(Image source: National Medical Products Administration)

The OX series oxygenator pack is indicated for use in conjunction with the STERIS OASSIST® extracorporeal cardiopulmonary support equipment to support patient's respiratory and/or circulatory functions by oxygenating and removing carbon dioxide from the blood for periods of up to 6 hours.

The product has the following features:

1 Lightweight and modular design: The kit is used together with the pump head driver to improve the efficiency and safety of emergency and critical care rescue while taking ease of operation and transportation flexibility into consideration.

2 STMed Silk Coating®: Reduces the adhesion of proteins and platelets during long-term use, which can substantially reduce the occurrence of thrombosis.

3 Structure of oblique runner: The internal flow field is uniform without dead area, and there is no area of high shear stress, with small pressure loss and low shear stress; the flushing is uniform and not easy to produce thrombus.

(Image source: STMed's official WeChat account)

During the clinical trial and registration application process of the product, Tigermed-Jyton overcomes multiple challenges during project execution with swift response and full chain synergy. The trial participants are 100% intensive care patients with rapidly changing conditions, and the enrollment window is extremely uncontrollable. The project team is ready to respond to the emergency enrollment needs at any time, ensuring zero delay in each emergency screening, informed consent, and trial process. Even with the large amount of real-time monitoring data, the team work together to efficiently and timely integrate diverse data fields, and finally complete cleaning and locking efficiently. At the same time, with accurate understanding of the regulatory requirements and abundant application experience, we successfully completed the compilation and submission of dossiers, and quickly responded to and answered professional questions during the review process, providing solid evidences for the smooth approval of products.

The successful approval of the single-use membrane oxygenator kit not only adds a new choice of China made quality devices for ICU critical care, but also highlights the professional strength and mission of Tigermed-Jyton in the full life cycle service of medical devices. Tigermed-Jyton will continue to support more innovative medical devices to accelerate to the market and contribute to the construction of world healthcare.

References:

1.      STMed's official WeChat account 2026/8/26 《New Product Launch | The STM OX-7000LT series of disposable membrane oxygenator kit is approved by NMPA for marketing！》https://mp.weixin.qq.com/s/0Z3jNAk-yNbqkfodMzUBww

About STMed

Jiangsu STMed Technology Co., Ltd. was established on July 24, 2018, focusing on advancing and breaking through core technologies in the field of life support, striving to become a world champion in its niche with strong driving force and global influence.