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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 meet the strict safety and performance standards required by the U.S. Food and Drug Administration (FDA), ensuring their efficacy and reliability.

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

In addition to our globally recognized certifications—including ISO 13485, FDA, RoHS, CE, EMC, and UL—we also offer professional certification assistance services. We can support you in obtaining key certifications such as UL, FDA, and 510(k), helping streamline the approval process. With our deep regulatory expertise and successful track record, you can accelerate your time to market, reduce costs, and ensure full compliance with local and international standards. This not only enhances your product’s market competitiveness but also builds greater trust among your customers.

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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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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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