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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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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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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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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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What are the properties of medical grade silicone?
Medical grade silicone is highly favored in the medical device industry because of its exceptional durability, versatility in molding, broad operational temperature range, resistance to chemicals, significant tensile strength, ability to withstand high temperatures, thermal stability, and a wide selection of hardness levels.
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What are the medical uses of silicone?
Silicones are utilized in skin treatments to enhance absorption and effectiveness. Additionally, silicone materials are highly sterilizable, which helps minimize the risk of bacterial infections.
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What are the benefits of medical grade silicone?
Medical grade silicone offers numerous benefits, including its biocompatibility, chemical inertness, nontoxicity, flexibility, translucency, and lack of odor or taste. It can be sterilized through multiple methods, making it a safe and reliable choice for medical and hospital environments.
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What silicone is used in medical devices?
While there are various types of silicones available commercially, the most frequently utilized in medical devices are HCR (High Consistency Rubber) and LSR (Liquid Silicone Rubber). HCR is produced by creating solid silicone rubber sheets and partially curing them with peroxide catalyst additives.
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Why is silicone rubber so widely used in medical applications?
Silicone rubber's extensive use in medical applications is due to its established benefits, such as excellent biocompatibility, desirable mechanical properties, resistance to chemicals and extreme temperatures, and versatile processing capabilities.
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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
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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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