Certificate

When it comes to medical equipment, certification is not just a requirement – it is a guarantee of safety, reliability, and compliance . Our oxygen concentrators are manufactured under strict international standards and hold the certifications required for global healthcare markets.

Continuous Flow Portable Oxygen Concentrator

Professional Certificates

Zhengzhou Olive Electronic Technology Co., Ltd. is a company specializing in the research and development, production and sales of oxygen concentrator. The factory strictly implements ISO9001 standards and all products comply with medical CE standards.

" The CE certification (Conformité Européenne)is a mandatory conformity marking for products sold in the European market. However, while General CE (non-medical CE) applies only to standard electronic and electrical products, Medical CE requires rigorous assessment by a Notified Body to ensure compliance with the Medical Devices Directive (MDD 93/42/EEC)

Our oxygen concentrators are certified with Medical CE (CE number: CE 0123) , meeting EU medical device regulations and legally authorized for sale and use in 32 EU and European Economic Area (EEA) countries/regions.

Medical CE certification covers product design, manufacturing environment, and production processes, ensuring that the equipment meets medical-grade safety, effectiveness, and quality standards. "

" ISO13485 Certification (Medical Device Quality Management System) is the globally recognized quality management system standard for medical devices.

As a medical device manufacturer, we strictly adhere to ISO13485 requirements to ensure our products meet the highest international quality standards.

Strict Quality Control: Covers the entire process, from raw material procurement to manufacturing, testing, packaging, storage, and after-sales service, ensuring product stability and safety.

Global Market Access: ISO 13485 certification is a key qualification for medical devices to enter multiple countries and regions, including the EU, USA, Canada, and Japan. "