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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!
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Medical Silicone Parts: The Significance and Impact of International Certifications like ISO and FDA
Exnan is a professional manufacturer that produces and develops all kinds of Silicone medical equipment accessories and silicone medical consumables, the main products including：Silicone oxygen mask parts、Silicone medical device accessories、Silicone medical consumables parts、Silicone button parts、Silicone extrusion parts、Silicone over mold parts
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Is medical grade silicone FDA approved?
Medical grade silicone rubber is a specialized form of silicone that adheres to the biocompatibility and safety criteria established by regulatory authorities such as the FDA and ISO. It is specifically designed for medical applications involving potential contact with human tissue, blood, and other bodily fluids.
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What is the quality control process of medical devices?
A prevalent technique for manufacturing medical grade silicone is injection molding. This involves forcing liquid silicone into a heated chamber made of metal or plastic under high pressure. The method ensures the production of a robust and resilient product by uniformly distributing heat across the material.
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Quality Control Measures in the Production of Medical Silicone Parts: Ensuring Safety and Reliability
Hey there! If you’re in the medical device industry, you know how critical it is to get every detail right—especially when it comes to silicone parts. Whether it’s a catheter, a seal, or a wearable device, the quality of these components can literally be a matter of life and death.
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Is medical grade silicone eco-friendly?
Medical grade silicone is neither biodegradable nor recyclable, making it less eco-friendly. It should not be disposed of in curbside recycling bins.
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Medical Silicone Parts: Trends in Eco-Friendly and Sustainable Material Choices
Medical silicone parts are widely used in healthcare. They are found in implants, tubing, seals, and catheters. Traditional silicone is not eco-friendly. This article explores sustainable trends in medical silicone.
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What makes silicone biocompatible?
The biocompatibility of silicones is primarily due to the molecular structure of dimethylsiloxane (Table 14.9) [29]. From a toxicological perspective, the dimethylsiloxane chain is non-cytotoxic. (Example: Silpuran medical adhesive tape with UV-curable silicone rubber adhesive coating, courtesy of Wacker Chemie AG.)
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Ensuring Biocompatibility and Safety Standards in Medical Silicone Parts: A Guide for the Medical Device Industry
If you work in the medical device industry, you know how important silicone parts are. These parts often touch patients’ bodies. So, biocompatibility and safety are not optional.
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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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