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 SURGICAL FACE MASK
ESTABLISHMENT NAMESIMPLY K SDN BHD
REGISTRATION NOGA8505621-72954
BRAND NAMESIMPLY K
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONDisposable surgical face masks comply with EN 14683 ‘Type IIR’ embedded with nose clip and ear loops or head loops. This surgical face mask made of 3-ply of premium non-woven fabric with Bacterial Filtration Efficiency (BFE) >98 and Splash Resistance Pressure > 16.0 kPa.
DEVICE INTENDED PURPOSEDisposable Surgical face mask that covers the user's nose and mouth and provides a physical barrier from transmission of viruses, microorganisms and dust. It is suitable to be use for surgical procedures to protect both patient and healthcare provider.
VALIDITY DATE OF REGISTRATION22/09/2021 - 21/09/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
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