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Our Certificates
US Food and Drug Administration (FDA) Testing Certificate
The U.S. Food and Drug Administration (FDA) is the highest-level law enforcement agency in the United States, authorized by emergency regulations. It is responsible for overseeing the safety and efficacy of food, drugs, medical devices, cosmetics, and radiation-emitting electronic products. Obtaining FDA approval or certification is a crucial prerequisite for the legal sale of related products in the U.S. market.
Federal Communications Commission Certification
FCC is the abbreviation for the Federal Communications Commission of the United States. Its certification is required for electronic devices to enter the U.S. market; they must obtain electromagnetic compatibility and wireless power consumption licenses to ensure that the products will not harm other devices.
EU safety certification
CE is a product safety conformity mark stipulated by EU law. It indicates that the product has met the basic requirements of a series of EU regulations on health, safety, and environmental protection, and is a mandatory passport for entering the European Economic Area market.
UK Conformity Assessment
UKCA is the UK Conformity Assessment Mark, a mandatory safety certification for products entering the British market. It indicates that a product meets the basic safety, health, and environmental requirements stipulated in relevant UK regulations, and serves as a license to enter the UK market.
The International Organization for Standardization develops environmental management system standards.
ISO 14001 is an internationally recognized environmental management system standard. It provides companies with a systematic framework for establishing, implementing, maintaining, and continually improving their environmental management system, aiming to help organizations fulfill compliance obligations, manage environmental risks, and improve environmental performance.
International Quality Management System Standard Certificate for the Medical Device Industry
ISO 13485 is an international standard for quality management systems specifically for the medical device industry. Building upon ISO 9001, it adds specific requirements related to medical device regulations, aiming to ensure the safety and effectiveness of medical devices throughout their entire lifecycle. It serves as the core quality management foundation for global medical device manufacturers to meet regulatory requirements and gain market access.
International Standard Certificate for Quality Management System
ISO 9001 is a quality management system standard published by the International Organization for Standardization. It provides companies with a framework and core requirements for establishing and implementing a quality management system, aiming to continuously and stably provide products or services that meet customer and regulatory requirements through systematic process management.
International Organization for Standardization Occupational Health and Safety Management System Standard
ISO 45001 is the international standard for occupational health and safety management systems. It provides companies with a systematic framework for identifying, controlling, and reducing work-related health and safety risks, aiming to prevent workplace injuries and illnesses and continuously improve workplace safety.
