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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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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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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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How do you make silicone more durable?
Plasticizers, commonly incorporated into silicone rubber, enhance flexibility and durability by reducing its glass transition temperature (Tg). This results in increased pliability and resistance to cracking or tearing.
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How to conduct an ISO 13485 audit?
Key phases for conducting an ISO 13485 internal audit: 1. Develop documented procedures for internal audits. 2. Create and maintain a program specifying the audit schedule. 3. Execute the audits according to the established plan. 4. Maintain documented evidence of both the audit plan and its execution. 5. Implement corrections to address identified nonconformities and eliminate their root causes. 6. Verify the effectiveness of the actions taken to resolve nonconformities.
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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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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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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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What is the best alternative to silicone?
Polyurethanes are commonly used for horizontal joints or vertical applications requiring non-sagging performance, available in both single- and multi-component formulations. To determine if a polyurethane sealant can directly replace silicone in a specific scenario, seek guidance from a technical specialist to ensure optimal selection.
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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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