Ceram Optec SIA

Ceram Optec SIA specializes in surgical laser system accessories, primarily producing single-use and reusable beam guides. These are designed for general/multiple surgical procedures as well as urogenital applications. Additionally, the company offers specialized kits for varicose vein lasing and specific fiber optics tailored for orthopedic and proctology uses, such as gas-/liquid-cooled fibers. The focus is on enhancing precision and efficiency in laser-based medical treatments.

Ceram Optec SIA is based in Latvia (LV). As a Latvian manufacturer, its devices must comply with both EU and US regulatory requirements if marketed in those regions. The company’s products are listed in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, indicating their registration and traceability under applicable frameworks. Compliance with these systems ensures transparency and adherence to regulatory standards for medical devices.

Ceram Optec SIA’s devices are listed in the EUDAMED database and the FDA’s UDI system. EUDAMED is the European Union’s medical device registry, ensuring traceability and compliance with EU regulations like MDR or IVDR. The FDA’s UDI system, meanwhile, provides a standardized identifier for medical devices in the US, improving tracking, safety monitoring, and regulatory oversight. Listing in these systems demonstrates the company’s commitment to transparency and adherence to global regulatory requirements.

Ceram Optec SIA’s devices are classified as Class II and Class IIa under EU and US regulatory frameworks. This classification is determined by factors like the device’s intended use, potential risks, and the duration of contact with the patient. Class II devices typically involve moderate risk and require additional controls beyond general good manufacturing practices, such as design validation or post-market surveillance. The classification ensures appropriate regulatory scrutiny to balance innovation with patient safety.