SMT’s Supraflex Cruz Receives EU MDR Certification

October 9, 2026—Sahajanand Medical Technologies Limited (SMT), an India-based global manufacturer of cardiovascular medical devices, announced that it has received certification under the European Union Medical Device Regulation (EU MDR 2017/745) for Supraflex Cruz and its product family.

According to the company, Supraflex Cruz is a sirolimus-eluting coronary stent system designed to improve luminal diameter in occluded or stenosed coronary vessels, including de novo lesions and restenosed vessels.

SMT stated that the certification comes after the conformity assessment process established under EU MDR 2017/745 including assessment of SMT’s technical documentation, clinical evaluation, and quality management system.

SMT further advised that the clinical evidence base for the device includes four randomized controlled trials involving more than 5,000 patients and seven real-world registries involving more than 13,000 patients, with findings published in leading peer-reviewed journals including The New England Journal of Medicine; JAMA: Journal of the American Medical Association; JACC: the Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; and BMJ Open.