Nuraleve – Regulatory Affairs

CE Marking

The Nuraleve delivery system features our latest medical device. The CE Marking was granted after verifying the safety and efficacy of our product.

CE Mark No. CE 593638
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Health Canada Medical Device License

The Nuraleve delivery system features our latest medical device. The medical device license was granted by Health Canada after verifying the safety and efficacy of our product.

Medical Device Licence No. 92093
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Health Canada Medical Device Establishment License

Nuraleve is licensed to import and distribute medical devices. The medical device establishment license was issued by Health Canada.

Medical Device Establishment Licence No. 5880
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ISO 13485:2016 Certification

nuraleve-bsi-iso-13485

The ISO 13485:2016 quality standard ensures our ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Our commitment to customer safety and design excellence is ensured through a certified quality management system in place for the design and manufacturing of medical devices.

Certified by: BSI Group
Certificate #: FS 592661

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ISO 13485:2016 Certification (MDSAP)

nuraleve-bsi-iso-13485

Nuraleve conforms with ISO 13485:2016 including Medical Devices Regulations – Part 1- SOR 98/282 for Canada, as part of the MDSAP program. The scope of this certification is design, development, manufacturing, and distribution of products used to modulate the nervous system, including transcranial direct current stimulation (tDCS).

Certified by: BSI Group
Certificate #: MDSAP 692355

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