JNBIO

JNBIO specializes in surgical devices, specifically the SPIRO LENIS, which is designed for intraocular lens (IOL) implantation during cataract surgery. This includes applications for toric and multifocal lenses, replacing the natural lens via phacoemulsification procedures.

JNBIO is headquartered in South Korea. While the company’s primary focus is on the SPIRO LENIS, its devices are listed in the EU’s eudamed database, indicating compliance with European Union regulatory requirements for medical devices.

The SPIRO LENIS is classified as a Class IIa medical device under EU regulations. This classification is based on its intended use in intraocular lens implantation, which carries a moderate risk level requiring additional scrutiny beyond basic safety checks.

JNBIO’s SPIRO LENIS is currently listed in the eudamed database, which is the official EU registry for medical devices. Listing in eudamed confirms the device’s compliance with EU regulatory requirements and its availability for use within the European market.