FORTE GROW MEDICAL CO., LTD.

Forte Grow Medical Co., Ltd. specializes in tubing sets designed specifically for blood purification procedures. These include applications in hemodialysis and other therapies where fluids and blood must be safely transferred, filtered, or cleansed during treatment. The company focuses exclusively on this category of medical devices.

Forte Grow Medical Co., Ltd. is based in Japan. While the company’s headquarters are in Japan, its tubing sets for blood purification are classified as Class IIa devices under EU regulations and are registered in the EUDAMED database. This indicates the devices are intended for use within the European market and must comply with EU regulatory requirements, even if the manufacturer is based outside the EU.

Forte Grow Medical Co., Ltd.’s tubing sets for blood purification are listed in the EUDAMED database. This registry is the official European Union database for medical devices, ensuring transparency and traceability of devices authorized for use within the EU. Listing here confirms compliance with EU regulatory processes for Class IIa devices.

Forte Grow Medical Co., Ltd.’s tubing sets for blood purification are classified as Class IIa medical devices. This classification is determined by the level of risk associated with the device, where Class IIa represents a moderate risk requiring specific conformity assessment procedures. The classification ensures that these products undergo rigorous evaluation to confirm their safety and performance before being authorized for use.