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China’s drug balloon dilatation catheter products obtained CE certification Hay:P02SHXM

Recently, the Chinese leading aortic and peripheral vascular interventional medical device technology company, SHXM Medical Technology Group issued an announcement that on December 10, 2020, the company obtained the CE for ReewarmTM PTX drug balloon dilatation catheter products issued by the international certification body UDEM Uluslararasi Belgeiendirme AS Certification certificate.

It is reported that the drug balloon dilatation catheter is suitable for balloon dilation of the femoral popliteal artery (except the inferior knee artery) in percutaneous transluminal angioplasty to treat atherosclerotic stenosis or occlusive disease.

In addition, obtaining the CE certification shows that the above-mentioned products meet the relevant requirements of the European Union and have the access conditions of the European Union market. They can be sold in the European Union and related overseas markets. The company's overseas sales of products will be further expanded.

About SHXM

SHXM is committed to R&D, manufacturing and sale of aortic and peripheral vascular intervention devices, and its main products are thoracic and abdominal aortic stent graft, stent in surgical operation, peripheral vascular stent and peripheral vascular balloon dilatation catheter, etc. 

It successfully developed the first abdominal aortic stent graft in China and its stent in surgical operation is the only device that has been approved to be applied in thoracic aortic dissection procedures in China. In addition,  It developed is the first approved branched aortic stent graft in the world. 

At present, SHXM 5 self-developed products has been approved by the national “Special Approval Procedure of Innovative Medical Device”, being in a leading position in the industry. In the area of aortic intervention devices, It has 5 thoracic and abdominal aortic stent grafts products which were approved, and is a global company with complete product lines in this segment.

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