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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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Manufacturing Process and Quality Control for Medical Device Silicone Parts
Hey there! If you're in the medical device manufacturing industry, you probably already know that silicone is a key material for many parts. But have you ever wondered about the entire manufacturing process and how to ensure that every single part meets the highest quality standards?
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How many types of silicone are there?
Silicone rubbers can be categorized into three main types based on their molecular structure: high-temperature vulcanized (HTV) silicone rubber, room-temperature vulcanized (RTV) silicone rubber, and liquid silicone rubber (LSR). HTV silicone rubbers are characterized by their high molecular weight polymers.
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Common Types and Uses of Silicone Parts in Medical Devices
Hey everyone, if you’ve ever wondered why silicone is such a big deal in the medical device world, you’re in the right place! Silicone is one of those materials that just keeps cropping up due to its amazing properties.
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What is the most common use of silicone?
Silicone rubber is widely utilized in many manufacturing sectors, ranging from kitchen utensils to automotive components, and is commonly used as a waterproof sealant, such as in bathrooms.
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Common Types and Uses of Silicone Parts in Medical Devices
Silicone is a wonder material in the medical device industry. It's not just because it's flexible and durable; silicone also has excellent biocompatibility and chemical resistance, making it a go-to choice for a wide range of medical applications.
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Is silicone safe for medical use?
Silicone is deemed safe for medical use due to its chemical stability and is believed to be non-toxic. This has made it a popular choice for cosmetic and surgical implants, such as those used to enhance the size of body parts like the breasts and buttocks.
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Ensuring Patient Safety with Medical Device Silicone Parts
When it comes to medical devices, patient safety is always the top priority. From surgical tools to implantable devices, every component must meet rigorous standards to ensure it is safe and effective.
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What are the benefits of silicone material?
Benefits of Silicone Rubber** Silicone rubber has a lot of advantages that other materials just can't match. It can stand up to extreme temperatures, resist chemicals and water, withstand harsh weather conditions, and provide excellent electrical insulation. Plus, it has a long lifespan, making it a great choice for many applications.
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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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