Regulatory for Lumohs Re-usable Battery Operated Handles- Only these models : NLS-1612-009; NLS-1631-009 and NLS-1641-009.
Nano’s products meet IEC 60601-1, IEC 60601-1-2, and IEC 62471, FCC compliance, Biocompatibility, ISO 7740, 21CFR 820 standards for GMP.
Lumohs is a FDA Class I Exempt device.
Lumohs meets NRTL testing requirements and is permitted to carry the SGS North America Mark as a visible sign of its compliance. It demonstrates the Lumohs commitment to product safety to our manufacturers, suppliers, retailers, regulators and customers.
To market products in the USA and Canada they must meet the relevant national safety standards.
As the premier Nationally Recognized Test Laboratory (NRTL) SGS has extensively tested and certified Lumohs for the US and Canadian market (NRTL Certification).
SGS NRTL Certification ONLY applies to Lumohs devices marked with the SGS NRTL Mark
