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lf you have any queries, get in touch today! Don't hesitate, We try to take the extra step forour customer satisfaction.
Hey there, I’m Steve!
I’m the sales manager of exnan medical silicone. I have been in this field for more than ten years. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
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Our certificate
Possess 800 square meters of Class 10,000 dust-free workshop, Passed ISO9001:2015 quality management system certification and ISO13485:2016 medical device quality management system, and its products have obtained multiple biocompatibility tests, US FDA and EU LFGB certifications.
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
Cooperating customers
Till now, Exnan products has been exports 35 countries, and more than 500 Medical equipment factory, health care companies, hospitals, clinics use our products, and win good reputation.
New
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
News
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
New Requirements of ISO13485:2016 for Medical Silicone Suppliers
Time： 2026-05-18 15:20:00
Author： Amber
Click：
The upgrade to ISO13485:2016 imposes higher requirements on medical silicone suppliers: risk management, process validation, full traceability, and clean environment control. Biocompatibility reports (e.g., ISO10993) are required for materials, and production parameters must be documented. Suppliers need a controlled documentation system and must accept customer audits. Companies with independent cleanrooms, precision testing equipment, and training systems gain competitive advantages. Guangdong
Since 2024, more and more Chinese medical component manufacturers have achieved ISO13485:2016 certification, which has become a basic threshold for entering the European and American medical supply chains. For medical silicone manufacturers, the new version imposes higher requirements in risk management, process validation, traceability, and clean environment control.
ISO13485:2016 emphasizes quality management throughout the entire product lifecycle. Controlled documentation must be established for every step, from raw material procurement, mold management, and molding parameter recording to finished product sterilization validation. Especially for silicone materials that may contact human tissue, biocompatibility test reports (e.g., ISO10993) are required.
Furthermore, the standard requires suppliers to demonstrate continuous improvement capabilities and accept customer audits. Companies with independent cleanrooms (Class 10,000 or higher), comprehensive testing equipment (CMM, tensile testers, aging chambers, etc.), and personnel training systems are more likely to secure long-term orders.
Guangdong Exnan Technology Co., Ltd. successively obtained ISO9001 and ISO13485 certifications in 2024. With an 800㎡ Class 10,000 cleanroom, over 45 production units, and a 30+ year R&D team, the company meets the strict audit requirements of international medical customers for silicone masks, medical consumables, and other products.
Visit us: www.exnan.com
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Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
EXNAN
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Copyright © 2004-2024 Guangdong Exnan Technology Co.,Ltd
+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
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