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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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Batch Traceability in Silicone Production: Your Shield Against Recalls & Quality Headaches
Hey there, medical device manufacturers across the pond! Let's talk about something that keeps operations folks up at night: product recalls. Especially when you're dealing with critical components like medical-grade silicone accessories. One weak link, one contaminated batch, and suddenly, your hard-earned brand reputation and bottom line are on the line.
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What is the difference between RoHS compliant and REACH?
Gamma radiation can sterilize objects sealed in impermeable packaging because it penetrates deeply.
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Autoclave vs. Gamma Radiation: Essential Guide to Sterilization Compatibility for Medical Silicone Components (2026)
So, you’re designing a medical device with silicone seals, gaskets, or plungers. Fantastic! Silicone’s biocompatibility and flexibility make it a superstar material. But here’s the million-dollar question that keeps engineers and procurement managers up at night:
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What is the difference between RoHS compliant and REACH?
RoHS targets 10 specific hazardous substances (like lead and mercury) within electrical and electronic equipment. REACH, in contrast, is a comprehensive regulation governing the manufacture, import, sale, and use of all chemical substances across industries within the EU.
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EU & US Compliance: Navigating RoHS vs. REACH for Medical-Grade Silicone Supply Chains
Hey, let's cut to the chase: $2M in medical device recalls happened last year because of non-compliant silicone components (according to EMA’s 2023 data). If you’re sourcing silicones for catheters, implants, or diagnostic equipment, confusing RoHS with REACH isn’t just annoying—it’s a $50,000-per-day violation waiting to happen.
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Is thermoplastic elastomer better than silicone?
Both silicone and TPE exhibit strong resistance to aging and weathering. However, TPE generally offers superior abrasion resistance, tear strength, and resistance to solvents. Silicone excels in electrical insulation and water repellency.
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Silicone Manufacturing Secrets: How to Choose Between LSR and SAM for Medical Devices
You're an engineer at a European medtech firm. The clock's ticking. Prototypes look great in SAM silicone, but will they scale affordably? Or meet EU MDR rules? Choosing between LSR injection molding and Silicone Additive Manufacturing (SAM) feels like walking a regulatory tightrope.
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How to Choose the Right Medical Silicone Supplier: Top 10 Must-Haves for OEMs
Let's face it—if you’re designing medical devices, silicone isn't just a material; it's a lifeline. From catheters to wearables, medical-grade silicone ensures safety, durability, and compliance. But here’s the kicker: not all suppliers are created equal.
MORE
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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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