International Certification

International Medical Device Certifications






The Aculife has received medical device certifications in multiple countries and regions, including:

Certifications:

  1. China (CFDA): The China Food and Drug Administration approval ensures that the device meets local safety and efficacy standards for medical devices.

  2. United States (FDA): The U.S. Food and Drug Administration certification confirms that the iDOC is safe for use and complies with regulatory requirements for medical devices.

  3. South Korea (KFDA): The Korean Food and Drug Administration approval indicates that the device meets South Korea's medical safety and performance standards.

  4. European Union (CE Certification): CE marking indicates that the device complies with European health, safety, and environmental protection standards.

  5. Taiwan (Ministry of Health and Welfare): The license from Taiwan's Ministry of Health and Welfare signifies compliance with local regulations for medical devices.

Patents:

The Aculife iDOC holds patents in several countries, protecting its technology and design innovations:

  • China

  • United States

  • Germany

  • South Korea

  • Taiwan

  • Japan

  • Australia

  • Russia

  • Thailand

  • Indonesia

  • Malaysia

These patents ensure that Aculife iDOC maintains a competitive edge and protects its intellectual property across various markets.

Aug 27,2024