DEVICE DETAILS
NAME OF DEVICE | N95 SMP ANTIBACTERIAL MEDICAL FACE MASK |
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ESTABLISHMENT NAME | DEXINA FLORAPRO RESOURCES (M) SDN. BHD. |
ROLE OF ESTABLISHMENT | MANUFACTURER |
REGISTRATION NO | GA3139322-94046 |
BRAND NAME | TRUVIGOR |
MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
DEVICE GROUPING TYPE | SINGLE |
DEVICE DESCRIPTION | TRADE MARK : TRUVIGOR MODEL : N95 SMP ANTIBACTERIAL MEDICAL FACE MASK RATING EN149 CLASSIFICATION =FFP2 SPLASH RESISTANCE TYPE :IIR [ FACE MASK TYPE RESPIRATORY PROTECTIVE DEVICE TO BE USED IN AND/OR OPERATING THEATRE OTHER MEDICAL SETTINGS] TEST REPORT :2021CE1949 , 2022CE0104, 03-14B-02-2022-39-03-1 , 2022CE010-S1 , 03-14B-02-2022-39-04-2 PRODUCT STANDARD: EN14683:2019 PRODUCT : MEDICAL FACE MASK SHAPE: 3D PROTECTIVE 5 PLY FACE MASK AVAILABILITY :SINGLE USE ONLY COUNTRY OF ORIGIN :MALAYSIA (MADE IN MALAYSIA) MANUFACTURER: DEXINA FLORAPRO RESOURCES (M) SDN BHD FEATURE :ANTIBACTERIAL ,ANTIVIRAL ,DEODORIZATION ,SAFE,COMFORTABLE ,STYLISH |
DEVICE INTENDED PURPOSE | TO BE WORN BY USER AND ACT AS PROTECTIVE BARRIER FOR NOSE AND MOUTH FROM LARGE PARTICLE DROPLETS SPLASHES , SPRAYS OR SPLATTER THAT MAY CONTAIN VIRUSES AND BACTERIA OR ANY OTHER AIR - BORNE PARTICULATES .THIS FACE MASK USED AS A SURGICAL MASK . |
VALIDITY DATE OF REGISTRATION | 08/06/2022 - 07/06/2027 |