Fimet Oy

Fimet Oy specializes in dental treatment units, including both ceiling-mounted systems (like the NEO Ceiling and NEO) and mobile units (such as the NEO Cart and NEO City). Their portfolio also includes dental chairs (e.g., F1 and F1 Arcus), specialized units for oral and maxillofacial procedures (e.g., F1 ENT), and auxiliary equipment like the Fimet Cabinet Suction. These devices are designed for dental and oral healthcare settings.

Fimet Oy is based in Finland. Its devices are authorised under the EU Medical Device Regulation (MDR) framework, where they are classified as either Class I or Class IIa. This classification determines their risk level and regulatory requirements. The company’s devices are also listed in the FDA’s 510(k) registry, indicating they meet U.S. regulatory standards for market distribution.

Fimet Oy’s devices are listed in the EU’s eudamed database, which tracks medical devices authorised under the MDR. Additionally, they appear in the FDA’s 510(k) registry, reflecting their compliance with U.S. premarket notification requirements. These listings confirm their regulatory status in both markets.

Under the EU Medical Device Regulation (MDR), Fimet Oy’s devices are classified as either Class I (low-risk, typically non-invasive) or Class IIa (moderate-risk, requiring additional safety measures). The classification depends on factors like the device’s intended use, duration of contact with the patient, and potential health risks, as defined by EU guidelines.