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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 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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What is the process of manufacturing silicone products?
It is produced by mixing silicone polymer with various additives such as crosslinkers, catalysts, and fillers through a process called compounding. The resulting mixture is then shaped into the desired form through techniques such as molding, extrusion, or calendaring.
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What is the difference between medical grade TPE and silicone?
Silicone excels in extreme environments, making it ideal for products that need to withstand high temperatures, chemicals, or repeated use, such as medical devices, kitchenware, or outdoor equipment.
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What are the medical applications of silicone rubber?
Silicone rubber is used in pacemakers, defibrillators, shunt systems, respiratory care products, inhalers, infusion therapy, drug delivery systems, peristaltic pump sets, diabetes care, dental care devices, medical devices, diagnostic equipment, blood dialysis, catheters, disposable fluid transfer manifolds and closure assemblies, and breastfeeding products, among others.
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Does medical grade silicone help scars?
Topical silicon gel is safe and effective treatment for hypertrophic and keloidal scars.
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Can you put silicone tape directly on a wound?
Do not apply silicone gel sheets directly to open wounds. If a wound forms on your scar, remove the silicone sheet and set it aside until the wound has healed. Make sure to clean the gel sheet regularly, as dirt or bacteria buildup can irritate the scar.
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Can medical grade silicone be sterilized?
medical-grade silicone is suitable for sterilization, as this process removes microbial contaminants to reduce the risk of infection or irritation. Sterilization can occur in a clinical setting or as part of the final steps in device assembly and packaging.
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How to make medical grade silicone?
One common method for producing medical grade silicone is known as injection molding, in which liquid silicone is injected under pressure into a heated metal or plastic chamber. This process creates a strong and durable final product due to the even distribution of heat throughout the material.
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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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