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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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Enhance Your Medical Devices with SIMTEC's High-Quality, FDA-Compliant Liquid Silicone Rubber Components
In the dynamic world of medical device manufacturing, the choice of materials is pivotal. Liquid Silicone Rubber (LSR) has emerged as a game-changer, offering unparalleled biocompatibility, flexibility, and durability.
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Why is Six Sigma critical for achieving zero defects?
Six Sigma equips organizations with data-driven tools to systematically enhance process efficiency. By minimizing variability and optimizing workflows, it directly reduces error rates while elevating product quality, operational profitability, and stakeholder confidence.
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Zero Defects, Maximum Trust: Advanced Quality Control for Medical-Grade Silicone Tubing in High-Volume Production
Did you know? Over 70% of medical device recalls stem from material defects.** For manufacturers sourcing silicone tubing, quality isn’t just a goal—it’s a mandate."
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What is the difference between liquid silicone and medical silicone?
Medical-grade silicone is distinct from standard liquid silicone in key aspects, including purity levels, biocompatibility certifications, compliance with medical regulations, and sterilization adaptability. These factors ensure safety for prolonged human contact.
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Why Medical Device Engineers Are Switching to LSR for Critical Parts
Ever struggled with designing medical components that demand both precision and durability? You’re not alone. In an industry where a fraction of a millimeter can make or break a device, Liquid Silicone Rubber (LSR) molding is emerging as the go-to solution.
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What is antimicrobial silicone?
Micra-Sil® antimicrobial silicone rubber combines the advantageous properties of traditional rubber with microbial resistance. This material actively eliminates bacteria and microorganisms while providing lasting protection against subsequent contamination. Key features include neutrality in taste and odor, safety for human contact (non-toxic), stability (no chemical leaching), and corrosion resistance.
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Ultra-Pure Silicone: Meeting ISO 10993 Standards for Implantable Devices
In the world of medical devices, biocompatibility is not just a buzzword—it's a lifeline. When it comes to implantable devices, the materials used must meet the highest standards to ensure patient safety and device performance.
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Ultra-Pure Silicone: Meeting ISO 10993 Standards for Implantable Devices
Imagine a pacemaker that lasts decades without triggering inflammation, or a breast implant that stays intact and safe for a lifetime. The secret? It’s not just the design—it’s the material. In the high-stakes world of medical implants, ultra-pure silicone is rewriting the rules.
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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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+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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