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 DEVICEKF94-SURGICAL FACE MASK
ESTABLISHMENT NAMEICON PACKAGING SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA2516721-81198
BRAND NAMESUNWAY
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single use non sterile and latex free device made of non-woven, structural filter and melt blown. Adjustable to fit faces of various shapes and sizes. The face mask tested for Bacterial Filtration Efficiency (BFE), Particle Filtration Efficiency (PFE) and Viral Filtration efficiency (VFE) that has sufficient protection against haze particles, dust and harmful droplets. It also high breathability, hypoallergenic, soft and lightweight.
DEVICE INTENDED PURPOSEA mask is meant to help block large particle droplets, splashes or splatter that may contain germs (viruses & bacterial) keeping it from it reaching to your mouth. Face mask may also help to reduce the exposure of your saliva and respiratory secretion to others. This device, is appropriate to be use by healthcare professional during surgical procedures to protect both the patient and healthcare personnel.
VALIDITY DATE OF REGISTRATION20/12/2021 - 19/12/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94-SURGICAL FACE MASKSW6001
2KF94-SURGICAL FACE MASKSW6006
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