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Global Certifications: Guaranteeing Safety and Performance

ISO 13485

We are ISO 13485 certified, ensuring that our devices are manufactured with consistent quality and meet international regulatory standards.

FDA

Our red light therapy devices are FDA registered and device listed, complying with applicable U.S. medical device requirements.

RoHS

Our devices are free from harmful substances, including lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, and DIBP, in line with RoHS regulations.

CE

We comply with European safety, health, and environmental protection standards, ensuring our devices meet all required EU directives.

EMC

Our products are tested and certified to meet electromagnetic compatibility (EMC) standards, ensuring they do not interfere with other electronic devices.

UL

Our devices are UL listed, meeting U.S. and Canadian safety standards, ensuring that they provide the highest level of safety and reliability during use.

Certification Support Services

Enter new markets with less compliance work. We provide available ISO 13485, CE, RoHS, EMC and UL-related documentation, as well as FDA registration and device listing information for applicable red light therapy models. From test reports and technical files to labeling and registration documents, our team helps distributors and private-label brands shorten preparation time, reduce avoidable delays and launch in selected markets with greater confidence.

Contact Our Team

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Download

CE
PDF 0.33MB
UL
PDF 0.13MB
FDA
PDF 0.11MB
EMC
PDF 0.33MB
LVD Certificate
PDF 0.31MB
X6-680W RC
PDF 9.67MB
EN 60335 Report
PDF 6.95MB
X6-680W FCC
PDF 0.25MB

Power Safety Certifications & Test Reports

In addition to our FDA, CE, RoHS, UL, and other certifications, we have compiled a dedicated collection of power safety certifications and test reports to further ensure the reliability of our products. At Magique Huaer, we prioritize transparency and compliance, giving you complete confidence in our technology.

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CONTACT US

If you have any queries, get in touch today! Don't hesitate. We try to take the extra step for our customer satisfaction.
Zhengzhou Magique Huaer Biotech Co., Ltd.
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