Certifications & Patents
Committed to excellence in medical device manufacturing, our products are backed by international certifications and proprietary patents, ensuring the highest standards of safety, quality, and innovation for surgical procedures worldwide.
International Certifications
Our products meet the highest international standards for safety, quality, and regulatory compliance.
CE MDR Certified
Full compliance with European Medical Device Regulation. Covers Vessel Sealing Systems, ultrasonic scalpel systems, and compatible surgical instruments for the European market.
- Class IIa Medical Devices
- EU Market Access
- Notified Body Approved
ISO 13485:2016
Quality Management System certified for the production and sale of disposable trocars, vessel sealers, ultrasonic scalpels, skin staplers, electrodes, clips, and surgical components.
- QMS Certified
- Full Product Range
- Valid until 2029
IEC 60601
Medical electrical equipment safety standards compliance, verified by CNAS certified laboratory testing.
- Electrical Safety
- CNAS Verified
IEC 60068
Environmental testing standards ensuring product reliability and durability under various conditions, verified by CNAS certified laboratory.
- Environmental Testing
- Reliability Verified
Patents & Innovation
Proprietary technologies and patented designs that set us apart in the medical device industry.
Bipolar Vessel Sealing Technology
Multiple patents covering core bipolar vessel sealing technology. Engineered with patent avoidance capability for global market distribution.
- 3 Core Patents
- Patent Avoidance Design
- Global IP Protection