Class 10,000 cleanroom certification
Medical Grade Silicone Accessories: Quality You Can Trust
Explore our range of precision-molded silicone components
What set us apart
Empowering your medical devices with our silicone component advantages
Manufacturing Expertise
- 20+ Years Master, Self-Built Factory, Injection Mold Design in Housing, 100% Custom Solutions
Strict
Certified Quality System
ISO 9001:2015, ISO 13485:2016, Biocompatibility Testing Report, Class 100K Cleanroom
Precision Engineering
In-Mold Visual Monitoring System, CCD Vision Inspection, Air tightness Testing, ±0.01mm Accuracy
Dual Cleanroom Strategy
Class 100K Cleanroom & Standard Facilities, Fully Compliant with FDA/EU MDR Regulations
优势
What set us apart
Empowering your medical devices with our silicone component advantages
Manufacturing Expertise
20+ Years Master, Self-Built Factory, Injection Mold Design in Housing, 100% Custom Solutions
Certified Quality System
ISO 9001:2015, ISO 13485:2016, Biocompatibility Testing Report, Class 100K Cleanroom
Precision Engineering
In-Mold Visual Monitoring System, CCD Vision Inspection, Air tightness Testing, ±0.01mm Accuracy
Dual Cleanroom Strategy
Class 100K Cleanroom & Standard Facilities, Fully Compliant with FDA/EU MDR Regulations
Our Precision Production Process
Manufacturing occurs on micron - calibrated molding machines with multi - cavity molds, boosting efficiency.
Real - time monitoring of parameters ensures quality control.
Molding production and development
We blend advanced tech and precision in medical silicone molding. Micron - calibrated machines with multi - cavity molds offer efficient output, monitored in real - time. Our R&D team partners with institutions to explore new materials/tech for cutting - edge parts.
Air tightness detection
In production, airtightness testing is conducted after key steps to ensure silicone accessories meet quality standards. It prevents leakage that can cause device malfunctions or endanger patients. Rigorous testing ensures reliable medical silicone products for quality solutions.
PREV
NEXT
生产流程
Our Precision Production Process
Manufacturing occurs on micron - calibrated molding machines with multi - cavity molds, boosting efficiency.
Real - time monitoring of parameters ensures quality control.
Molding production and development
We blend advanced tech and precision in medical silicone molding. Micron - calibrated machines with multi - cavity molds offer efficient output, monitored in real - time. Our R&D team partners with institutions to explore new materials/tech for cutting - edge parts.
Professional production equipment
We are equipped with state - of - the - art injection molding machines that ensure high - precision molding of silicone parts. These machines can achieve micron - level accuracy, which is crucial for producing components that fit seamlessly into medical devices.
Quality is in our DNA
Certified excellence in every inspect of your projects
Class 10,000 cleanroom certification
ISO 9001:2015
ISO 13485:2016
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Pyrogens
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for sesame oil extraction
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Cell toxicity test:agar diffusion method
证书
Quality is in our DNA
Certified excellence in every inspect of your projects
Class 10,000 cleanroom certification
ISO 9001:2015
ISO 13485:2016
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Pyrogens
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for sesame oil extraction
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Cell toxicity test:agar diffusion method
Contact Exnan to start your Projects
Have questions about our precision medical silicone components? Contact us now using the details below.
Precision, quality, and reliability are the hallmarks of our medical silicone components. At Exnan, we are dedicated to providing solutions that meet the highest industry standards. Let us help you achieve excellence in your medical applications. Get in touch with us today to explore our offerings
联系我们
Contact Exnan to start your Projects
Have questions about our precision medical silicone components? Contact us now using the details below
Precision, quality, and reliability are the hallmarks of our medical silicone components. At Exnan, we are dedicated to providing solutions that meet the highest industry standards. Let us help you achieve excellence in your medical applications. Get in touch with us today to explore our offerings
+86-0752-3869959 / 3869960
+86 180 0752 8206
Building 8, China-Korea Emerging Intelligent Manufacturing Industrial Park, No.27, Songbailing Road, China-Korea (Huizhou) Industrial Park, Zhongkai Area, Huizhou City, Guangdong Province, China
