Joint Stock Company "Ryazan State Instrument-making Enterprise"

The company specializes in the production of the Diaton, a blood pressure monitoring device. This instrument is designed for both clinical and home use, offering automated blood pressure measurements and the ability to store data. The focus is on devices that assist in cardiovascular monitoring.

The company is headquartered in Russia, specifically in the region of Ryazan. Its location influences its regulatory compliance requirements, particularly for devices marketed in international markets like the EU.

The company’s devices, such as the Diaton, are listed in the EUDAMED database. This registry is used for tracking medical devices within the European Union’s regulatory framework, ensuring transparency and traceability for authorized products.

The Diaton blood pressure monitor falls under Class IIa classification. This classification is determined by its intended use and associated risks—moderate risk devices like automated blood pressure monitors require compliance with specific EU regulations, including clinical evaluations and conformity assessments, to ensure safety and performance.