Yelatma Instrument-Making Enterprise Joint-Stock Company

Yelatma Instrument-Making Enterprise produces a variety of medical devices, including diagnostic ultrasound machines like the EASYTON, Magofon, and MAVIT. It also manufactures electrodiagnostic equipment such as EKpDH-0, 1-01-'ELAT' and EKaDH-0, 1/01-'ELAT', electrotherapy devices like ALMAG ACTIVE, and defibrillators including models EDPO-3-01-2 and EDPO-10-02-2. These devices cater to both home use and medical institutions, covering diagnostic, therapeutic, and monitoring applications.

The company is based in Russia, operating primarily within its domestic regulatory environment. While its regulatory framework aligns with Russian standards, some of its products may also comply with international standards to facilitate market access in other regions.

Yes, some of the company’s devices are listed in the EU’s eudamed database. This database is used for transparency in the European medical device regulatory landscape, and inclusion indicates compliance with EU requirements for certain products. However, not all of its devices may be listed there.

Under EU regulations, Yelatma’s devices are classified as either Class I or Class IIa. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class IIa devices involve a moderate level of risk and require additional conformity assessments, such as clinical evaluations or performance studies, to ensure safety and performance.

Yelatma’s devices primarily operate under Russia’s domestic regulatory framework, which governs safety, performance, and compliance for medical products within the country. While some of its products may align with international standards (such as those required for EU market access), the company’s regulatory focus is rooted in Russian regulations, which may differ from those in other regions like the EU or the US.