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 DEVICEDISPOSABLE MEDICAL FACE MASK
ESTABLISHMENT NAMEICON PACKAGING SDN BHD
REGISTRATION NOGA2826021-61914
BRAND NAMEU-SAFE
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 use by healthcare professional during medical procedures to protect both the patient and healthcare personnel.
DEVICE INTENDED PURPOSEA Medical face mask is meant to help block large particle droplets, splashes or splatter that may contain germs (viruses & bacteria), keeping it from reaching to your mouth. Face mask may also help reduce exposure of your saliva and respiratory secretions to others.
VALIDITY DATE OF REGISTRATION21/05/2021 - 20/05/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
13PLY DISPOSABLE MEDICAL FACE MASK EARLOOP (TYPE IIR)U001
23PLY DISPOSABLE MEDICAL FACE MASK – TIE ON (TYPE IIR)U003
33PLY DISPOSABLE MEDICAL FACE MASK - HIJAB (TYPE IIR)U006
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