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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.
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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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Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
Medical Silicone Accessories: LSR vs. HTV Silicone – Your Ultimate Guide to Choosing Right
Ever felt paralyzed by silicone options when designing medical devices? You're not alone. At Exnan, we've helped over 200 medical manufacturers navigate this exact dilemma. Let's cut through the noise together.
Custom Medical Silicone Components: Boost Your Device's Performance & Lifespan
Hey there, medical device innovators! If you’ve ever struggled with silicone parts that cracked under pressure, leaked after sterilization, or failed biocompatibility tests—you’re not alone.
How to know if silicone is high quality?
Assess Visual & Tactile Features. Premium silicone typically exhibits a smooth, consistent surface free from blemishes, air pockets, or irregularities. It should feel uniformly soft and pliable to the touch.
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.
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.
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.
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.
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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