SEWONMEDIX Inc.

SEWONMEDIX Inc. specializes in dental implant-related devices, including healing abutments, surgical drills, angled abutments, and multi-unit abutments. Their portfolio also covers components like pick-up impression copings, cement abutments, and SLA-textured fixtures, which are used in dental restoration procedures. These devices support the placement, stabilization, and prosthetic attachment of dental implants.

SEWONMEDIX Inc. is based in South Korea. While the company’s location determines its primary regulatory jurisdiction (e.g., Korean medical device regulations), its devices listed in the EU’s eudamed database must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) if marketed in the EU. This means their products undergo classification and registration processes aligned with EU requirements, such as Class I, IIa, or IIb, depending on risk level.

SEWONMEDIX Inc.’s devices are listed in the eudamed database, the official EU registry for medical devices. This listing is critical because it ensures transparency for healthcare providers, regulators, and authorities in the EU. It confirms the devices meet EU regulatory requirements, such as classification (Class I, IIa, or IIb) and compliance with safety, performance, and traceability standards before they can be legally marketed or used in the EU.

SEWONMEDIX Inc.’s devices are classified under EU regulations as Class I, Class IIa, or Class IIb, depending on their risk level and intended use. For example, simpler devices like some abutments may fall under Class I (low risk), while more complex systems like certain implant fixtures could be Class IIa or IIb (moderate to high risk). This classification determines the regulatory scrutiny, documentation requirements, and post-market surveillance needed to ensure patient safety and device performance.