Lepios Solutions Registered as a Medical Device Manufacturer

Lepios Solutions LLC is pleased to announce that it has been registered as a medical device manufacturer by the Governor of Kanagawa Prefecture, pursuant to Article 23-2-3, Paragraph 1 of Japan's Act on Pharmaceuticals and Medical Devices (PMD Act).

In Japan, manufacturer registration is required for each manufacturing site that performs processes such as design, main assembly, sterilization, or domestic storage of finished medical devices. To be registered, a company must establish the structure required by law, including appointing a responsible engineer at each manufacturing site.

Following our license for the sale and rental of specially controlled medical devices, this registration further strengthens our framework for handling medical devices. We will continue to comply with all applicable laws and regulations, maintain rigorous quality control, and provide products that healthcare institutions can use with confidence.

We appreciate your continued support.

Registration Overview

• Registration type: Medical Device Manufacturer

• Registration No.: 14BZ200461

• Date of registration: June 29, 2026

• Valid through: June 28, 2031

• Registering authority: Governor of Kanagawa Prefecture

• Manufacturing site: Lepios Solutions LLC, 7F Blue Water Bldg., 2432-1 Noborito, Tama-ku, Kawasaki, Kanagawa, Japan