Sahajanand Medical Technologies Won EU MDR Certification
The company secured regulatory approval for its Supraflex Cruz coronary stent system in the European Union.
Updated on Sept. 29, 2026 in Heart Disease
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Sahajanand Medical Technologies has received EU MDR 2017/745 certification for its Supraflex Cruz coronary stent system. This regulatory milestone ensures that the company can continue to supply the device to patients across the European market.
Why it matters
The certification confirms that the stent system meets stringent global requirements for safety, performance, and clinical evidence. This approval supports the continued use of the device in treating patients with occluded or stenosed coronary vessels.
The device has been used in over 2.5 million patient treatments worldwide. Clinical evidence supporting this certification includes data from 5,000 patients across four randomized controlled trials and 13,000 patients in seven real-world registries.
The players
Sahajanand Medical Technologies
Headquartered in Mumbai, India, this company specializes in the development and manufacturing of coronary stent systems and cardiovascular devices.
The details
Sahajanand Medical Technologies achieved this status after completing a rigorous conformity assessment of its technical documentation, clinical evaluations, and quality management systems. The sirolimus-eluting stent is designed to treat blocked or narrowed coronary vessels and is now cleared for continued use in major European markets including Germany, Spain, and Poland.
Timeline
September 29, 2026: Sahajanand Medical Technologies announced the receipt of EU MDR certification.
March 31, 2025: The company recorded a footprint across 75 countries.
July 25, 2025: The date Sahajanand Medical Technologies filed its DRHP with SEBI.
Health Landscape
This certification confirms the product meets the stringent safety and performance requirements established by the EU Medical Device Regulation 2017/745. The move aligns with a broader trend of medical device manufacturers tightening documentation and clinical data to maintain compliance under updated European standards.
This regulatory approval ensures that patients in European hospitals will maintain uninterrupted access to the Supraflex Cruz stent for critical cardiac procedures. Physicians can continue to utilize this device for treating coronary artery disease with the confidence provided by the recent clinical validation.
The takeaway
Coronary stent technology continues to evolve under stricter regulatory oversight that demands robust clinical trial data. Patients and providers should look for devices that consistently meet these updated safety benchmarks to ensure long-term cardiovascular health.
Further reading
For more information on the management of coronary conditions, visit our Heart Disease section.
Source note: This article includes information reported by ETHealthworld.
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