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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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Is platinum silicone the same as medical grade silicone?
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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Understanding the Differences Between Medical Grade Silicone and Industrial Grade Silicone
Silicone is an incredibly versatile material, used in everything from kitchenware to spacecraft components. It’s known for its flexibility, durability, and resistance to heat and chemicals.
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What is the difference between industrial-grade and medical-grade silicone?
Medical-grade silicone differs from industrial-grade silicone primarily in terms of purity, biocompatibility, and regulatory requirements. Medical-grade silicone must meet stringent safety standards, undergo rigorous testing for biocompatibility, and be suitable for direct contact with human tissues. Industrial-grade silicone, while highly durable, allows for more flexibility in its composition and is designed to meet the specific needs of industrial applications like sealing, insulation, or lub
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Medical Grade Silicone vs Industrial Silicone: Understanding the Differences and Applications
Silicone is a versatile material used in many industries, from healthcare to construction. Despite its widespread use, not all silicone is created equal.
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Why is silicone used in medical devices?
Silicone is used in medical devices due to its chemical stability, durability, and elastic nature, making it ideal for long-term implantation in the human body. It is known for its biocompatibility and biodurability, supported by its inherent chemical and thermal stability, low surface tension, and ease of sterilization.
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Understanding the Role of Silicone in Modern Medical Device Manufacturing
As the global demand for medical devices continues to surge, driven by technological advancements and an aging population, the importance of selecting the right materials cannot be overstated. Within this context, silicone stands out as a crucial material, offering unique qualities that align perfectly with the needs of medical device manufacturing.
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Why Silicone is the Material of Choice for Medical Device Innovation
As medical technology advances, the demand for reliable, safe, and versatile materials continues to rise. Enter silicone—a superstar in the world of medical device innovation.
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What medical devices are made of silicone?
Silicones are widely used in medical devices because they are biocompatible, biodurable (do not degrade over time), do not produce extractables (a concern with leaching plasticizers from flexible PVC), and are unlikely to cause allergic reactions (a concern with latex).
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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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