Shanghai SGO Medical Technology Co., Ltd.
Learn more about our company and mission
Company Profile
About SGO Medical
Shanghai SGO Medical Technology Co., Ltd. is a leading medical device manufacturer headquartered in Shanghai, China. Founded in 2015, we specialize in the research, development, manufacturing, and global distribution of high-quality surgical instruments, diagnostic equipment, and rehabilitation devices.
Our Mission
To improve patient outcomes worldwide by delivering innovative, reliable, and accessible medical technology solutions. We are driven by the belief that every patient deserves access to world-class medical devices, regardless of their location.
Our Capabilities
Operating from our 8,000㎡ ISO-certified manufacturing facility in Shanghai, we combine advanced manufacturing technologies — including 5-axis CNC machining, automated assembly, and precision injection molding — with rigorous quality management systems to produce medical devices that meet the highest international standards.
Our products are registered and sold in over 50 countries across six continents, serving hospitals, surgical centers, rehabilitation facilities, and distributors. With a team of 200+ professionals including 45 dedicated R&D engineers, we invest 12% of annual revenue in research and development to drive continuous innovation.
Core Values
- Quality First: Every product undergoes rigorous quality inspection. Our ISO 13485 certified QMS ensures consistent excellence.
- Innovation Driven: With 68 patents and a robust R&D pipeline, we continuously push the boundaries of medical technology.
- Customer Centric: We build lasting partnerships through exceptional service, technical support, and responsive communication.
- Global Responsibility: As a WHO GHEI member, we are committed to improving healthcare access in underserved regions.
Our Journey
Company Founded
Shanghai SGO Medical Technology Co., Ltd. established in Pudong New Area, Shanghai, with initial focus on surgical instrument manufacturing.
First Product Line
Launched our first product line of disposable laparoscopic trocars, achieving sales in domestic market.
ISO 13485 Certification
Achieved ISO 13485:2016 quality management system certification from TÜV SÜD, opening doors to international markets.
CE Marking & EU Market Entry
Obtained CE marking for surgical instruments and entered European market through distribution partnerships.
FDA Registration & Expansion
Completed FDA establishment registration and 510(k) clearance for key products. Expanded factory to 5,000㎡.
Global Partnership Network
Established distribution partnerships in 30+ countries. Launched diagnostic equipment and rehabilitation device product lines.
Innovation & Growth
Won CMEF Innovation Award. Completed factory expansion to 8,000㎡. Serving customers in 50+ countries with 200+ employees.
Certifications & Qualifications
ISO 13485:2016
Quality Management System for Medical Devices certified by TÜV SÜD. Demonstrates our commitment to consistently meeting customer and regulatory requirements.
CE Marking (MDR 2017/745)
Full compliance with EU Medical Device Regulation for Class I, IIa, and IIb devices. Enables market access across 27 EU member states.
FDA 510(k) Clearance
FDA premarket clearance for surgical instruments and diagnostic devices. Registered establishment with annual listing updates.
ISO 14001:2015
Environmental Management System certification demonstrating our commitment to sustainable manufacturing and environmental responsibility.
Good Manufacturing Practice (GMP)
NMPA GMP compliance for medical device manufacturing. Class 100,000 clean room production environment.