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 DEVICESURGICAL FACE MASK
ESTABLISHMENT NAMEICON PACKAGING SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA2852220-49344
BRAND NAMEIcon Protective
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single use,non sterile and latex free device made of 2 layer of non woven and 1 layer of melt blown. Adjustable to fit faces of various shapes and sizes. The middle layer of face mask ( Melt blown ) which tested for Bacterial Filtration Efficiency that has sufficient protection against haze particles, dust and harmful droplets. It also high breathability, hypoallergenic, soft and lightweight. This device is appropriate to be used by healthcare professional during surgical procedures to protect both the patient and healthcare personnel.
DEVICE INTENDED PURPOSEA surgical face mask are intended to be worn by personnel to avoid transfer of bacteria, microorganisms and dust. Face mask may also help reduce exposure of your saliva and respiratory secretions to others.
VALIDITY DATE OF REGISTRATION09/11/2020 - 08/11/2025

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
13PLY SURGICAL FACE MASK - EARLOOP (TYPE IIR)3001
23PLY SURGICAL FACE MASK - EARLOOP (ZIPLOCK) (TYPE IIR)3002
33PLY SURGICAL FACE MASK - TIE ON (TYPE IIR)3003
43PLY SURGICAL FACE MASK - HIJAB (TYPE IIR)3006
53Ply Surgical Face Mask Premium
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