Incuram

Incuram specializes in hair implant systems. These devices are designed for surgical procedures to restore hair growth in patients with hair loss. The systems include components specifically for the precise implantation of hair follicles into the scalp, intended for use only in clinical settings by trained medical professionals.

Incuram is based in South Korea. While the company adheres to applicable regulatory standards for its medical devices, it is important to note that regulatory approvals or clearances apply to individual devices, not the company itself. The devices are developed to meet the requirements of their respective markets, including those in the EU.

Incuram’s hair implant systems are classified as Class IIa medical devices under EU regulations. This classification is determined based on factors such as the intended purpose, potential risks, and the degree of intervention involved in the procedure. Class IIa devices are considered to pose a moderate risk and require compliance with specific regulatory requirements, including clinical evaluations and conformity assessments.

Yes, Incuram’s hair implant systems are listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers and devices that have undergone regulatory processes (such as conformity assessment) are recorded. Listing in EUDAMED confirms that the device has been reported to the relevant authorities, though it does not imply individual approval or clearance.