Certifications & Achievements

Globally certified for quality, safety, and excellence in surgical disposables

Our Commitment

Globally Certified. Clinically Assured

At Surgeine Healthcare, excellence is our standard. Our certifications reflect our commitment to delivering safe and reliable products. From CE marking under EU MDR 2017/745 to ISO 13485:2016 and SFDA approvals, we meet the highest global standards. As India's only Star Export House in our field. Every product undergoes rigorous testing in our in-house labs, ensuring uncompromised quality for surgical settings.

Surgeine - Globally Certified
Quality Assurance

Our Certifications

Every certification we hold represents our unwavering commitment to delivering safe, reliable, and globally compliant surgical disposables.

CE Mark (EU MDR 2017/745)
CE Mark (EU MDR 2017/745)
Since 2008

Demonstrates conformity with EU Medical Device Regulation for our full range of surgical disposables.

ISO 13485:2016
ISO 13485:2016
Current

Medical device quality management system certification — the global benchmark for consistent, safe manufacturing.

BIS Certification
BIS Certification
Current

Bureau of Indian Standards certification for conformity with Indian standard specifications.

ZED Gold
ZED Gold
Current

Zero Defect Zero Effect certification recognising excellence in manufacturing quality and sustainability.

1 Star Export House
1 Star Export House
Current

India's highest export status category — awarded to organisations with outstanding export performance.

Intertek – Total Quality
Intertek – Total Quality
Current

Third-party verification of product quality, safety, and performance by Intertek laboratories.

Our Impact

Global Trust Earned Through Quality

16+Years Serving Industries
25+Countries, Trusted Worldwide
300+Active Global Partners
12Medical Product Categories
200+Skilled Workforce
Recognition

Achievement

Recognised by leading industry bodies and institutions for our commitment to innovation, quality, and global healthcare impact.

Award Trophy

Request Certification Documents

Need copies of our certification documents for compliance purposes? Contact us and we'll share the relevant documentation promptly.

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