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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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Why 83% of Medical Device OEMs Switch Silicone Suppliers (And What You Should Demand)
Hey engineers, I know you've been there. Have you ever stayed up all night, worried sick about silicone seals failing biocompatibility tests or mold flashing ruining an entire batch of surgical tools? Well, you're not in this alone. In fact, four out of five medical OEMs we've talked to are actively rethinking their silicone partners after facing those costly setbacks.
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Why is silicone used in medical devices?
ilicone is often chosen for medical devices because it is biocompatible, chemically inert, non-toxic, flexible, and translucent. It also lacks odor or taste. Furthermore, silicones can be easily sterilized using various methods, ensuring safety in healthcare environments. This combination makes them suitable for disposable items like many catheters and tubing.
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Why Medical-Grade Silicone Is Essential for Advanced Healthcare Devices
Hey medical device innovators! Ever feel like choosing materials for your next-gen device is like walking a tightrope? Balancing biocompatibility, cost, and performance keeps you up at night.
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What are the benefits of medical-grade silicone?
Silicone advantage in medical High stability in adverse temperatures and resistance to chemical and thermal degradation. Conformable and soft to the touch. Superior hydrophobicity offers lubricious coating for syringes and surgical tools. Exceptional water repellency to ensure bacterial resistance.
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Medical-Grade Silicone Components: Slashing Patient Risk & Boosting Comfort in FDA/CE Devices
Hey folks, let’s cut to the chase: if you’re designing medical devices in Europe or North America, silicone isn’t just another material—it’s your frontline defense against recalls, patient harm, and regulatory headaches.
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Is silicone cheap to produce?
Producing silicone is costly due to significant production expenses. Creating its key component, silica (derived from sand), involves an expensive, time-consuming, and energy-intensive process requiring specialized equipment.
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Maximize Efficiency & Cost Savings: Custom vs. Off-the-Shelf Silicone Components
Medical silicones aren’t just pretty tubing. They're the: - Seals keeping bodily fluids out of electronics - Valves controlling life-critical drug dosages - Membranes enabling lab-on-a-chip diagnostics
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How is silicone graded?
Silicone rubbers are categorized by their intended purpose. Common grades include Food Grade (kitchen utensils like spatulas and cake molds), Medical Grade (healthcare products such as tubing/catheters), Industrial Grade (machinery parts and seals), and Flame Retardant Grade (where fire resistance is essential).
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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
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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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