Atomizer Plate For Eye Atomization Instrument

When purchasing, international customers prioritize atomizer plates that have passed regulatory certification for their target market, avoiding product market closures due to lack of certification. For the European and American markets, customers require 13.8mm steam eye mask atomizer plates to be CE certified (compliant with EU REACH regulations on the restriction of hazardous substances and EU RoHS 2.0). For medical use, atomizer plates must also be CE MDR certified (EU Medical Device Regulation, typically classified as Class I or Class IIa). For the North American market, FDA registration is required (as a medical device component or food contact part), and oral nebulizer atomizer plates must meet FDA 510(k) pre-clearance requirements (if the end product is a medical-grade oral care device). In the Japanese and Korean markets, customers require KFDA certification (for medical-grade products) and Ministry of Health, Labor, and Welfare certification (for food contact and medical device component standards). Furthermore, material testing reports must be issued by locally recognized third-party organizations (such as KTL in Korea and JIS in Japan). For example, ceramic atomizer plates require a ceramic purity test report and a heavy metal leachable test report (to comply with Article 37 of the Japanese Food Sanitation Law).

 

For global markets, customers also look for ISO 9001 quality management system certification (to ensure controllable production processes), ISO 13485 medical device quality management system certification (for medical applications), and BPI compostability certification (for disposable atomizer plates, ensuring environmental compliance). These certifications are not only essential for market access but also serve as valuable assurance of product quality and safety, significantly enhancing customer trust.