Medpark Company Kossel Medtech Celebrates Dual Milestones: NMPA Approval and EU MDR Certification
Kossel
Vascular Interventional Device Manufacturer and R&D Developer
Recently,Jiangsu Medical Device Technology Park MedparkKossel Medtech (Suzhou) Co., Ltd., a company in the park, has continuously delivered good news. Cathios Cold Front, developed by its subsidiary Suzhou Haiyu Xincheng Medical Technology Co., Ltd.,®Disposable Saline Irrigation Radiofrequency Ablation Catheter, ObtainedApproved for marketing by the National Medical Products Administration (NMPA) (Registration Certificate No. 20253011078). Meanwhile, Kossel Medtech (Suzhou) Co., Ltd., the parent company, independently developed Selethru®PTCA Balloon Dilation Catheter ObtainedEU MDR CertificateThe successive approvals and certifications indicate that the company's products have met stringent standards for quality, safety, and efficacy both in China and internationally, laying a solid foundation for the company to expand into the global market.
Kossel Medtech (Located in the South Area of Jiangsu Medical Device Technology Park）Founded in 2013, it has become a platform enterprise in the field of vascular interventional devices. SubsidiarySuzhou Haiyu Xincheng Medical Technology Co., Ltd. (Located in the South Area of Jiangsu Medical Device Technology Park）Deeply engaged in the field of cardiac electrophysiology, committed to providing comprehensive solutions for the treatment of tachyarrhythmia.
Approved for marketing in China
Perfecting the Cardiac Electrophysiology Product Matrix
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Cathios Cold Front®Disposable Saline Irrigation Radiofrequency Ablation CatheterComposed of electrodes, catheter body, and handle assembly, used in conjunction with a radiofrequency ablation generator for the treatment of tachyarrhythmias through radiofrequency ablation.
The launch of this product will further enhance HAIYU Xincheng's product portfolio in the cardiac electrophysiology field, providing clinicians and patients with more precise and effective treatment tools.
EU MDR Certification
Accelerate the Expansion of the Global Market Map
Selethru®PTCA Balloon Dilatation CatheterMainly used for the expansion treatment of coronary artery stenosis or intravascular stents, with a tip entry diameter of only 0.016 inches, featuring Kolphnic.®Hydrophilic coating, tri-leaflet folding wing technology, and over-support wire taper design provide the catheter with superior pushability and trackability through advanced laser welding processes.
Previously, Selethru®The PTCA balloon dilation catheter has been successively launched in regions such as Asia and South America. This EU MDR certification will further accelerate Kossel's pace in the global market layout.
It is reported that currently, Kossel Medtech holds over 40 Class III medical device registration certificates in and outside China. In April this year, Kossel Medtech successfully completed a nearly 100-million-yuan B+ round of financing. The funds will mainly be used for core product research and development, global market promotion, and production capacity expansion. In the future, Kossel Medtech will continue to adhere to innovation-driven development, providing more excellent solutions for clinical use, and allowing innovative technologies to benefit patients worldwide.
Next, Jiangsu Medical Device Technology Park Medpark will continue to adhere to the purpose of serving enterprises, continuously optimize the industrial ecosystem of the park, fully utilize the advantages of resource integration and platform, and help more medical device companies enhance their global market competitiveness.