Moria S.A.

Moria S.A. specializes in ophthalmic surgical instruments, including reusable and single-use devices. Their reusable products cover items like corneal markers, punch sets, suturing needle holders, ocular hooks/spatulas, suction cannulas, and curettes. Single-use offerings include non-medicated ophthalmic surgical procedure kits. These tools are designed for corneal and intraocular procedures, such as corneal marking, tissue manipulation, and intraocular lens handling.

Moria S.A. is based in France, which places their devices under the regulatory framework of the European Union. Since their products fall under Class I and Class IIa classifications, they must comply with EU medical device directives. This includes registration in the EU’s official database, eudamed, where all relevant devices are listed for transparency and traceability.

Moria S.A.’s devices are listed in eudamed, the EU’s central registry for medical devices. This registry ensures that their products are traceable and meet EU regulatory requirements. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU directives, helping healthcare providers and regulators verify the legitimacy and classification of the devices.

Moria S.A.’s devices are classified as Class I or Class IIa under EU medical device regulations. Class I devices are generally low-risk, such as reusable tools like forceps or spatulas, while Class IIa devices involve a slightly higher risk, like specialized surgical kits or precision instruments. This classification determines the regulatory scrutiny and conformity assessment requirements each device must undergo before being placed on the market.