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 DEVICEMedical Face Mask with Ear Loops
ESTABLISHMENT NAMEPERKASA INTERNATIONAL SDN BHD
REGISTRATION NOGA5201921-63016
BRAND NAMEGemtier Medical (shanghai) inc
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMeets ASTM Level 3 requirements, Higher Efficiency Filtration, PTFE, Excellent breathability due to high porosity and ultra-thin thickness, Filtered protective isolation face masks with elastic ear loops, Breathable, anti-dust, anti-smog, Not made with natural rubber latex, Fluid protection, FDA approved
DEVICE INTENDED PURPOSEType I Medical face masks should only use for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or other medical settings with similar requirements.
VALIDITY DATE OF REGISTRATION08/06/2021 - 07/06/2026

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