... ~ 250g, White/Blue, CE, ISO, FDA & EN ISO 13485 certificates Specifications:1) Meeting the international quality ... adapt to variousface-shapes with comfortable sealing. 4) The high-efficient and strong electrostatic filtering ... .5/3.5kgwith CE and ISO9001-2000 / EN ISO 13485 certificates. FDA was assigned to us ... certificates, we have ISO, CE, FDA(510K), EN ISO 13485, Nelson Lab. Our products have been ...