Certification You Need To Check
FOFO has got all necessories certifications include ISO13485, CE MDR, FDA 510K, FSC,IEC60601 for your to register MEDICAL device easily in your Country. You can ask us sent you documents as assistant.
CE/CB:
FOFO has update all major products reqistered under MDR Regulation (EU) 2017/745 through it’s EC Representative MedNet EC-REP GmbH. A CE Mark ceritificate is needed in order to market medical device in theEuropean.
FDA:
FOFO air compression therapy system and nebulizers have got FDA 510K since 2019. The Mattress and cushions, massager ect also been registered at FDA since 2016. Be free to selling in USA market.
CFDA:
CFDA is abbreviation of The China Food and Drug Administration. FOFO medical air mattress and nebulziers under class II regulation， Supervision and management and annual review by the Food and Drug Administration.
IS0 13485:
2016 This registration is subject to the company maintaining a quality management system for medical device
FSC:
The Certificate of Free Sale issued by the Food and Drug Administration in China. Certificate for exportation of medical device , certify the products have been registered to be manufactured and sold in China, The exportation of the products are not restricted.
NRTL:
SGS issued NRTL certificates for USA and Canada market equal to UL for enter into hospital and products by insurance covered easily
MHRA:
FOFO medical air mattress and Air compression therapy system has got MHRA UK under Medicines & Healthcare products Regulatory in UK
ANVISA:
FOFO has got ready for products testing reports and factory audit by SGS. Can provide assistant for Brazil customer doing register and got Anvisa within 3-6months.
MDMA:
FOFO medical has got SFDA registered for medical air mattress , nebulizer and Air compression therapy sytem. Sell free to Saudi Arabic.
Testing reports:
FOFO medical has got IEC60601, EMC, LVD, Reach, RoHs, WEEE, POP, PRO65, ISO10993 ,FCC, ect. for help customer register in their countries .