Product Name: Medical Isolation Eye Mask Goggles High Quality PC Materia Anti-Impact Logo Printing: With Logo Printing Group: Adult Quality Guarantee Period: Two Years Material: PVC+PC Standard: En166 ANSI/Isea Z87.1 Transport Package: 48*44*32.5cm, 60PCS/Box, 6.2kg Specification: Size: 18*9CM; thickness: 3.5CM Origin: China Product Description Product: Isolation goggles for medical use.Exported Region: EU members and USA.Manufacturer Cert: ISO13485 cert issued by TUVSince goggles fall into classification of Class I device, the availability of ECDOC and MHRA registration allows manufacturer to print CE on packing for exporation to EU.only Class II and Class III device requires to present CE cert with NB code when buyer does Customs clearnce in EU.Product has been officially registered in FDA with Owner Operator Number: 10066262Manufactuer ECDOCTest Report issued by Shenzhen Precision Eyewear Testing & Inspection Services Co., LtdRegistration in MHRAISO 13485 cert issued by TUVCert of Compliance issued by Guangzhou Institute of MicrobiologyClean Workshop Test report JJ20191607 AbstractGMP 100,000 level aseptic workshop area covering 3,000 square meters