Following its successful registration with Singapore’s Health Sciences Authority (HSA), Kossel Medtech’s Selepump® Inflation Device has now obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), officially gaining access to the Japanese market.

With this latest milestone, Selepump® has secured four major international regulatory approvals, including EU CE 2797, U.S. FDA, Singapore HSA, and Japan PMDA , further expanding its global market access.

Designed as an accessory device for PCI procedures, the Selepump® Inflation Device features a highly accurate pressure gauge and a safety-lock mechanism to ensure stable inflation and safe pressure release. Its ergonomic handle is designed to enhance comfort during prolonged clinical procedures, while a comprehensive range of specifications meets the diverse requirements of vascular interventional procedures, delivering both safety and ease of operation.

The successful entry into the Japanese market marks another important step in Kossel Medtech’s global expansion strategy. Looking ahead, Kossel will continue to focus on vascular intervention, uphold the highest international quality standards, and provide safe, efficient, and high-quality solutions for healthcare professional worldwide, ultimately improving patient outcomes across the globe.