SEIKAGAKU CORPORATION

Seikagaku Corporation specializes in injectable hyaluronic acid-based products. These include devices like HyLink, used for soft tissue augmentation in dermatological procedures, and SUPARTZ, a gel formulation intended for joint-related applications. The products are designed to provide structural support or volume restoration in specific areas of the body.

Seikagaku Corporation is headquartered in Japan. While the company’s devices are developed and manufactured there, they are also marketed in regions like the EU, where they must comply with local regulatory standards. For example, in the EU, its products fall under Class III classification due to their high-risk nature, requiring strict adherence to regulatory requirements such as registration in eudamed.

Seikagaku Corporation’s devices are listed in the eudamed database, which is the EU’s official registry for medical devices. Listing in eudamed is mandatory for manufacturers placing Class III devices on the European market, as it ensures transparency, traceability, and compliance with EU Medical Device Regulations (MDR). This registry helps healthcare professionals, regulators, and patients verify the legitimacy and classification of the devices.

Seikagaku Corporation’s devices are classified as Class III in the EU. This classification is reserved for high-risk medical devices that pose significant risks to patients if they malfunction, such as those used for structural support or joint augmentation. Class III status requires rigorous pre-market approval, post-market surveillance, and compliance with stringent manufacturing and quality standards to ensure safety and efficacy.