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Sino-Biocan's CELL-LAV achieves EU MDR certification

Date:2024-05-29Edit:Sino-Biocan


Sino-Biocan's CELL-LAV has obtained CE certification for MDR Class I medical devices, marking a milestone in meeting the European Medical Device Regulation (MDR) standards across technology, quality, and management systems. This certification further solidifies Sino-Biocan's prominent position in the medical device sector and promises enhanced product quality and services for the European market and global customers.

 

The CELL-LAV is widely used in blood stations, hospital blood banks for blood sub-packaging and preparation, as well as pipeline connections and bagging operations in biopharmaceutical companies and immunotherapy centers. Tailored for various blood bags and biopharmaceutical bags, this transfer system operates efficiently at 300W, reducing transfer time effectively and offering different fusion temperature settings to meet PVC pipeline fusion requirements. This advanced equipment possesses the following features:

Sealed sterility, utilizing a bag-to-bag sterile docking method;

1、The equipment is equipped with a screen, displaying real-time transfer temperatures for convenient and user-friendly operation;

2、Independent fusion slice consumables, with each package containing 100 slices, showing real-time slice temperatures and remaining quantities, simplifying fusion slice production through a heating device;

3、 Capable of achieving sterile pipeline connections in regular environments;

4、Able to connect pipelines of similar and different diameters, suitable for dry-dry, dry-wet, and wet-wet pipeline connections;

5、 Blood bags connected via CELL-LAV retain the composition and shelf life of their contents.

 

Sino-Biocan is dedicated to providing cutting-edge solutions to the medical industry, recognizing the significance of technological innovation and quality management in the field. Sino-Biocan is ready to collaborate with a wide range of clients, continuously exploring innovation to drive the development in the medical device sector and striving to offer superior products and services to customers. Through collaboration, we are confident in collectively expanding markets and achieving mutually beneficial outcomes. Additionally, Sino-Biocan will continue to strengthen efforts in international market expansion, actively expanding into global markets to deliver high-quality medical device products and solutions to a broader international customer base.

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