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Hey there, I’m Steve!
I’m the sales manager of exnan medical silicone. I have been in this field for more than ten years. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
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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.
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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!
News
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
What is the difference between RoHS compliant and REACH?
Time： 2025-06-04 10:34:58
Author： Guangdong Exnan Technology Co.,Ltd
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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.
Q: What is the difference between RoHS compliant and REACH?
A: 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.
Q: Is silicone RoHS compliant?
A: RoHS restricts hazardous materials in electronic products. Compliance confirms silicone rubber adheres to these limits, ensuring it lacks restricted substances. This makes it appropriate for use in electronics and medical devices.
Q: What is the difference between RoHS and REACH SVHC?
A: The key differences lie in scope and substance focus. RoHS restricts 10 specific substances only in Electrical and Electronic Equipment (EEE). REACH SVHC addresses 224 Substances of Very High Concern present in virtually any product manufactured or sold in the EU. Both set crucial compliance benchmarks for manufacturers and importers.
Q: Does RoHS apply to medical devices?
A: Yes. RoHS restricts hazardous substances specifically in Electrical and Electronic Equipment (EEE), which includes any electronic components within medical devices. REACH restricts hazardous chemicals used in the production of *any* product, medical devices included.
Q: Does REACH replace RoHS?
A: No. REACH and RoHS are distinct, complementary EU regulations. While both aim to control hazardous substances, REACH has a vastly broader scope, applying to nearly all goods and chemicals. RoHS is a directive focused exclusively on substances within Electrical and Electronic Equipment (EEE). One does not supersede the other.
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Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
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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