To further expand the global medical device export market and strengthen the international competitiveness of Chinese wound care products, our company has successfully passed the EU CE MDR Class II medical device certification audit for the full series of PBT elastic bandages. All product parameters, manufacturing standards and safety management systems fully comply with the latest EU medical device regulations, enabling legal sales and circulation across all 27 EU countries. This certification covers high-elastic breathable PBT bandages, self-adhesive elastic bandages, post-operative fixation bandages, sports protection bandages and other complete wound care product lines, marking the full compliance of our core Wound Care Supplies with high-end international market entry standards and completely breaking the EU market access barriers.
As a professional manufacturer and exporter focusing on medical wound care consumables and beauty auxiliary devices, our factory owns Class 10,000 dust-free purification workshops, fully automatic sterile production lines and an independent product testing laboratory. This CE MDR certification is another important international qualification following US FDA registration, Saudi SFDA certification and ASEAN regulatory approval. Compared with ordinary medical bandages, our upgraded PBT elastic bandages adopt modified PBT fiber materials with high elasticity, high air permeability, hypoallergenic performance and excellent skin fitting ability. The products are widely used in surgical dressing fixation, medical beauty wound repair, sports injury protection and daily wound care, perfectly meeting the diversified demands of consumers in Europe, America, the Middle East and Southeast Asia.
With a complete international qualification system, our foreign trade business has achieved comprehensive upgrading. We now support large-scale wholesale, customized OEM/ODM services and small-batch cross-border e-commerce orders worldwide. Meanwhile, we provide one-stop services including medical device compliance consultation, localized label customization and multilingual certificate document matching. In the future, we will continue to focus on the segmented wound care track, continuously upgrade product technology and quality, optimize the global supply system, expand the export share of medical dressings, and build a high-standard, high-quality and cost-effective Chinese medical device export brand.
The Company’s Full Range of PBT Elastic Bandages Officially Obtained EU CE MDR Certification
The Company’s Full Range of PBT Elastic Bandages Officially Obtained EU CE MDR Certification