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lf you have any queries, get in touch today! Don't hesitate, We try to take the extra step forour customer satisfaction.
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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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How to Select a Reliable Custom Medical Silicone Accessories Manufacturer: 10 Questions You Can’t Afford to Miss
Hey there, medical device innovators! If you've ever lain awake at night worrying about the quality of silicone parts, lead times, or compliance issues, go grab yourself a cup of coffee. We're here to cut through all the distractions and show you how to thoroughly evaluate manufacturers before you make a commitment.
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What is the difference between food grade and medical-grade silicone?
While both are safe for their intended uses, medical-grade silicone undergoes stricter testing and refinement for biocompatibility within the body. Food-grade silicone is approved for food contact but doesn't meet the biological compatibility requirements for medical applications.
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Medical-Grade Silicone Secrets: Stop EU/US Compliance Headaches Before They Start
"Picture this: You’ve spent 18 months developing a breakthrough catheter. Months before launch, regulators kick it back because your food-grade tubing leaches plasticizers. Suddenly, that ‘cost-saving’ material just triggered €200K in redesigns.
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What is considered medical-grade silicone?
Medical-grade silicone refers to a synthetic, non-toxic, and inert elastomer. To earn this designation, it must pass rigorous biocompatibility assessments confirming its **safety and stability during prolonged interaction with bodily tissues and fluids.
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Global Compliance - Ready LSR Components: Custom Medical Silicone Solutions for OEMs
Hey everyone! Let's face the facts. If you're in the market for silicone for catheters, implants, or diagnostic equipment, you're not simply purchasing parts. You're investing in risk management.
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Regulatory-Compliant Custom Silicone Parts: 5 Advantages Over Off-the-Shelf for Medical Devices (FDA/CE Focus)
Regulatory-Compliant Custom Silicone Parts: 5 Advantages Over Off-the-Shelf for Medical Devices (FDA/CE Focus)
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How do you manufacture silicone parts?
Silicone parts are most often produced using injection molding. This process injects liquid silicone rubber (LSR) under high pressure into a mold. Due to the material's thermosetting properties, thorough distributive mixing is essential. This high-volume method yields flexible and long-lasting parts.
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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.
MORE
Recent News
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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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