Third Party Certificates
We Have All the Necessary Product Certificates and Factory Qualification Certificates.
FDA No. (3033883954)
Certificates issued by the U.S. Food and Drug Administration can be found on the official FDA website.
ISO 13485
ISO 13485 is a quality management system standard for use in the medical device regulatory environment.
IEC60601
IEC 60601 is a series of standards developed by the International Electrotechnical Commission (IEC).
CE
The CE marking means that the seller declares that his product complies with the requirements of European regulations.
ISO9001
ISO9001 refers to a quality management system certification standard developed by the International Organization for Standardization (ISO).
ISO14001
ISO4001 Environmental Management System Certification is an environmental management system standard issued by the International Organization for Standardization (ISO).
ISO45001
ISO 45001 is an occupational health and safety management system standard published by the International Organization for Standardization (ISO).
FCC
FCC certification is a mandatory certification of electronic products in the United States.
BSCI
The BSCI certification is a Business Social Standard certification designed to ensure that a company’s social responsibility performance in global supply chains meets international standards.
ROHS
RoHS certification is a mandatory standard established by European Union legislation. Its full name is the “Restriction of Hazardous Substances Directive.”
MDL
The Canadian Medical Device License (MDL) is equivalent to the U.S. FDA’s 510(k) clearance.
Certificate of Incorporation
This is the registration certificate of WAKELIFE’s parent company Sungrow in Hong Kong.
TGA
The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods such as medicines, medical devices and diagnostic tests in Australia.