Archive · 25 Sep 2026
Sahajanand Medical Technologies Gains EU MDR Certification for Supraflex Cruz
Sahajanand Medical Technologies makes medical devices for treating heart blood vessels.
The company announced that its Supraflex Cruz stent received certification under European medical-device rules.
These rules require checks of a product’s safety, performance and clinical evidence.
Reviewers assessed the company’s technical documents, clinical evaluation and quality system.
Supraflex Cruz is designed to help widen coronary blood vessels that are blocked or narrowed.
The company says the product has supported treatment for more than 2.5 million patients in over 75 countries.
Its evidence includes four clinical trials involving more than 5,000 patients.
It also includes seven real-world registries involving more than 13,000 patients.
SMT said the certification should help maintain product supply and patient access in Europe and other markets.
Sahajanand Medical Technologies received EU MDR 2017/745 certification for Supraflex Cruz and its product family.
The certification followed assessments of technical documentation, clinical evaluation and the company’s quality management system.
Supraflex Cruz is a sirolimus-eluting coronary stent designed for occluded or stenosed coronary vessels.
The product has supported treatment for more than 2.5 million patients across over 75 countries.
SMT said the certification supports continuity of supply and patient access in Europe and globally.
- Who
- Sahajanand Medical Technologies Limited, including CEO Bhargav Kotadia and CTO Abhijeet Singhvi.
- What
- The company received EU MDR 2017/745 certification for Supraflex Cruz and its product family.
- When
- September 24; the articles do not specify the year of the announcement.
- Where
- The announcement was issued from Mumbai, Maharashtra, India, and concerns access across Europe and globally.
- Why
- The certification followed assessment of safety, performance, clinical evidence, technical documentation and quality systems, while supporting continuity of supply and patient access.
- Company
- Sahajanand Medical Technologies Limited
- Certified product
- Supraflex Cruz and its product family
- Regulation
- European Union Medical Device Regulation 2017/745
- Product type
- Sirolimus-eluting coronary stent system
- Patient reach
- More than 2.5 million patients in over 75 countries
- Clinical evidence
- Four randomized controlled trials involving more than 5,000 patients
- Real-world evidence
- Seven registries involving more than 13,000 patients
