Our core wound care product series has officially completed US FDA medical device registration, obtaining legal market access qualification for the United States, Canada and North American regions. The registered products include PBT elastic bandages, disposable wound dressings, medical cold compress repair patches and other mainstream Wound Care Supplies, marking our official entry into the high-standard North American medical and beauty consumer market.
The US FDA has extremely strict review standards for medical consumables, requiring comprehensive inspection of product safety, production environment, quality system and clinical applicability. After multiple rounds of document review, sample testing and factory audit, our production system and product quality fully meet FDA regulatory requirements. With FDA certification support, our products can be legally sold through Amazon US local warehouses, offline medical distributors and American beauty salon chains.
North America has high consumer demand for high-quality sterile wound repair and beauty postoperative care products. Our certified products have achieved excellent market feedback, with continuous growth in bulk wholesale and cross-border retail orders. In the future, we will continue to apply for more international certifications, enrich global market access qualifications, and steadily expand the market share of Chinese medical consumables in North America.