Our Commitment to Quality
HEZE YINUO MEDICAL maintains the highest standards of quality in the manufacturing of disposable medical supplies. Our certifications demonstrate our commitment to international quality standards and regulatory compliance.
ISO 13485:2016
ISO 13485 is an internationally recognized quality management standard specific to the medical device industry. This certification ensures that our processes consistently meet customer and regulatory requirements for medical devices.
CE Marking
CE Marking indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Our products meet all relevant EU directives for medical devices.
FDA Registration
Our facility is registered with the U.S. Food and Drug Administration (FDA), ensuring compliance with American regulatory requirements for medical device manufacturing.
Free Sales Certificates
Free Sales Certificates (FSC) confirm that our products are freely sold in their country of origin and are manufactured according to Good Manufacturing Practices. We hold FSCs for both China and Europe.