... ~ 250g, White/Blue, CE, ISO, FDA & EN ISO 13485 certificates Specifications:1) Meeting the international quality criteria (Europe): EN149:2001 ... 5.5/3.5kgwith CE and ISO9001-2000 / EN ISO 13485 certificates. FDA was assigned to us in ... the certificates, we have ISO, CE, FDA(510K), EN ISO 13485, Nelson Lab. Our products have been exporting ... levels of our organization. Dust mask (EN ISO 13485 approved)