New Year's Good News! Biosis Healing Obtained the Country's First CE certificate of Animal Source Mesh Product EU CE certificate

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EU CE certificate

The New Year began with good news.

On February 12, Biosis Healing obtained the European Union CE certificate for its non-crosslinked extracellular matrix derived biomaterials (SIS biomaterials) product - biological hernia graft with independent intellectual property right.This is the first and so far the only animal-derived mesh product in China that has obtained the EU CE certificate! The certificate represents our research results in the field of SIS biomaterials have been in a leading position in the world and have been recognized by the European Union!

CE certificate

DNV GL (formerly Det Norske Veritas), with a history of 157 years, conducted the CE certificate for us this time. With the tenet of "safeguarding the safety of life and property and protecting the environment", DNV GL is extremely strict in the examination of products of animal-derived, which is in line with the corporate philosophy of Biosis Healing. From the initial selection of animal-derived materials, environmental requirements, production process to animal experiments, clinical experiments and product marketing, Biosis Healing has always adhered to the tenet of "safety, effectiveness and environmental protection" and put the health and safety of patients in the first place.

SIS material - hernia graft

As we all know, CE certificate is the European Union mandatory requirements for products based on the uniform technical specifications, with the EU CE mark, also marks the product and process to meet the world-class standards.

The CE certificate of the first SIS biomaterial mesh product of Biosis Healing in China is obtained, which represents the recognition of Biosis Healing in the international market. Since then, in the international market, Chinese SIS biomaterial products have obtained the admission card, with the strength to compete with the international first-line well-known brands, the world will once again witness the power of Chinese science and technology, made in China!

About Biosis Healing SIS biomaterials:

The SIS biomaterial, with independent intellectual property rights of Biosis Healing, adopts fresh animal submucosal tissues as raw materials, removes risks such as immunogenicity, retains the structure of natural extracellular matrix and active ingredients, and can induce endogenous regeneration and repair after implantation in vivo, so as to realize tissue function regeneration. It can be completely degradable in vivo, and has the advantages of resisting infection and preventing adhesion. It is suitable for the regeneration and repair of almost all soft tissues in the human body. It is the only regenerative medicine material with platform property and can be applied to all surgical lines.

Before the establishment of Biosis Healing, the United States was the only company in the world that had the technology to produce a full range of extracellular matrix derived biomaterials, and in the early 1990s, the United States had begun to use such materials for tissue repair, while China was still using non-biodegradable synthetic materials. Around 2010, foreign biomaterial mesh entered China, the price was high.Biosis Healing has solved a series of key issues such as animal source risk control, immunogen removal, biological activity retention, controllable degradation and product molding, and independently completed the development of SIS material technology platform, breaking the foreign monopoly. Hernia graft is the first product of Biosis Healing SIS biomaterials. It has obtained the China National Medical Products Administration Class III medical device registration certificate in 2018 and has been marketed in China.