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GeneJet Biotech to develop Class III medical devices

Source: Taiwantrade | Updated: 30 October 2017

GeneJet Biotech, Taiwan's first company dedicated to the development and production of biomedical adhesives, has announced that it will be entering the field of Class III medical devices.

The U.S. FDA classifies medical devices based on the risks associated. Devices are classified into one of three categories—Class I, Class II, and Class III. For example, while dental floss is deemed low risk and considered a Class I device, acupuncture needles are considered Class II due to the higher risks involved, and replacement heart valves are considered as Class III medical devices.

According to GeneJet, the company is now in the final stages of commencing the development of its Class III product, and is planning to achieve CE and Taiwan certifications within the next 2 years.

In 2014, GeneJet became the first company in Taiwan to deliver biomedical adhesives, which are Class II medical devices that can take the place of sutures for closing up wounds.

The company's star product, TissueAid™, is designed for wound closure and wound care treatment, and serves the needs of hospitals, clinics and physicians.

With decades of experience in manufacturing medical adhesives, GeneJet is capable of carrying clients' ideas from design into finished products.

The company provide services from material selection, design consultation, tool making, prototyping, sterilization, regulatory required testing to pre-production run and mass production.

With ISO 13485 and 9001 certified facilities, all products will be manufactured in class 100,000 cleanroom by fully automated equipment and skilled operators.

GeneJet Biotech will be exhibiting at the upcoming Medica trade fair in Düsseldorf from Nov. 13 to 16, 2017.

Source: China Times
Lillian Lee (lillianlee@taitra.org.tw)


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