This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICEFRONTIFIE 3-PLY PREMIUM MEDICAL FACE MASK
ESTABLISHMENT NAMENEUTROVIS SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA5902723-129108
BRAND NAMEFRONTIFIE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThis single use medical face mask with BFE >= 98% and PFE >=98% is made from premium medical grade melt-blown filter fabric that will protect you from germs, bacteria and viruses. The soft, non-woven, inner material of the mask provides better comfort and reduced irritation. It is able to filter out live bacteria (viable particles) from 5 to 1 micron and micro particles (nonviable particles) from 1 to 0.1 micron
DEVICE INTENDED PURPOSETHIS 3 PLY DISPOSABLE MEDICAL AND SURGICAL FACE MASK IS A NON-WOVEN MATERIAL THAT OFFERS FILTRATION-EFFICIENT, FLUID-RESISTANT, SUPERIOR COMFORT AND BREATHABILITY TO HELP REDUCE WEARER TO EXPOSURE OF POTENTIALLY INFECTIOUS PARTICLES, BLOOD AND BODY FLUIDS . IT IS DESIGNED TO BE USED IN HOSPITAL ESPECIALLY IN OPERATING THEATER AND CLEAN ROOM ENVIRONMENT.
VALIDITY DATE OF REGISTRATION29/04/2023 - 28/04/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Frontifie 3-Ply Premium Medical Face Mask - Blush PinkOTR003
2Frontifie 3-Ply Premium Medical Face Mask - Iris PurpleOTR005
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