IVISMILE Certifications

As a leading B2B OEM/ODM manufacturer of professional teeth whitening and oral care solutions in China, IVISMILE holds multiple international quality certifications and patented innovations. Our products meet the strictest regulatory standards in the European Union, United States, and United Kingdom—ensuring safety, efficacy, and supply-chain transparency for global private-label partners.

Factory Qualification Certifications

Our China-based factory has been audited and certified to:

  • ISO 13485 (Medical Device QMS)
  • MDSAP (Multi-Country Medical Device Audit)
  • ISO 9001 (Total Quality Management)
  • GMP (Good Manufacturing Practice)
  • ISO 22716 (Cosmetic GMP for EU)
  • BSCI (Business Social Compliance Initiative)
  • Halal Certification (Exclusively for the Muslim market)

“These factory-level credentials underscore IVISMILE’s dedication to world-class quality management and ethical supply-chain practices for private-label oral care.”

Product Safety & Compliance

IVISMILE’s range of gels, strips, toothpaste, powders, and mouthwash comply with:

  • EU CPNP & UK CPSR (Cosmetic Product Notification)
  • FDA (US Food & Drug Administration)
  • MSDS, Heavy Metals, Microbial Challenge & Stability Testing
  • Halal Certification

“Certified safe for end-users—supporting OEM partners in navigating global cosmetic regulations.”

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Electronic Equipment Certifications

Our LED lamps, U-type lights, electric toothbrushes, and irrigators carry:

  • CE-EMC / CE-LVD & UKCA (EU/UK Market Access)
  • FCC (USA Electromagnetic Compliance)
  • RoHS (Restriction of Hazardous Substances)
  • IPX6/IPX7, EN 62471, EN 60335 (Safety & Durability)
  • Patents (Appearance & Utility)

“Robust electrical and optical safety certifications ensure reliable performance for global OEM dental devices.”

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