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.


DEVICE DETAILS

NAME OF DEVICESUPER SURGICAL FACE MASK
ESTABLISHMENT NAMESIN HUAT PRESS (MELAKA) SDN BHD
REGISTRATION NOGA3111521-52105
BRAND NAMESUPER
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONProcedure surgical face mask is a 3-ply disposable mask consisting of 3 layers, which are the outer hydrophobic non-woven layer, the middle melt-blown layer, and an inner soft absorbent non-woven layer, with ear loops at both sides of the masks. It is meant for single use and intended for protection against transfer of microorganism, droplets and airborne particulate. The outer non-woven layer is a water proof layer to prevent absorption of droplets while the meltblown layers serves to contain droplets by electrostatically adsorbing them on the surface hence it cannot infiltrate the mask; whereas the inner layer is intended to absorb water, sweat and saliva. It comes with ear loops and a nose strip.
DEVICE INTENDED PURPOSEIntended for single use to protect against transfers of microorganisms, droplets and airborne particulates by preventing large droplets or splatters that could possibly contains microorganism from entering the body through nose and mouth as well as to prevent from transmitting droplets or splatters that could possibly contains microorganism to others.
VALIDITY DATE OF REGISTRATION12/01/2021 - 11/01/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1SUPER SURGICAL FACE MASKSM-SFM-3001-0