MEDIVANCE INSTRUMENTS LIMITED

Medivance Instruments Limited specialises in dental devices, primarily automated x-ray film processors like the ExtraXtender and IntraX, which process radiographic films for dental imaging. They also produce abrasive air jet systems, such as the Velopex AquaCut Fluid Abrasion Unit, which uses fluid abrasion for dental treatments. Additionally, the company supplies related consumables, including fluids like AquaSol, sodium bicarbonate powders, and ergonomic accessories like foot pedals.

Medivance Instruments Limited is based in the United Kingdom. The company’s headquarters and operations are located within the country, which influences its regulatory compliance and device listings.

Medivance Instruments Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These registries ensure transparency and traceability of devices under their respective regulatory frameworks.

Medivance Instruments Limited’s devices are classified as Class I, Class II, and Class IIa under EU and FDA regulations. Class I devices generally pose the lowest risk, while Class II and Class IIa devices involve higher risks and require additional regulatory scrutiny, such as conformity assessments or post-market surveillance.