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.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICEDisposable Medical Face Mask
ESTABLISHMENT NAMESIMPLY K SDN BHD
REGISTRATION NOGA2640421-68154
BRAND NAMEPOP K
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONDisposable medical face masks comply with EN 14683 ‘Type IIR’ embedded with nose clip and ear loops or head loops. This medical 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 Medical face mask that covers the user's nose and mouth and provides a physical barrier from transmission of viruses, microorganisms and dust. It is intended to be use by healthcare provider and other persons for medical purposes and to control infectious diseases, particularly in epidemic or pandemic situations.
VALIDITY DATE OF REGISTRATION03/08/2021 - 02/08/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1DISPOSABLE SURGICAL FACE MASKADULT SURGICAL FACE MASK - EAR LOOP
2DISPOSABLE SURGICAL FACE MASKADULT SURGICAL FACE MASK - HEAD LOOP
3DISPOSABLE SURGICAL FACE MASKCHILDREN SURGICAL FACE MASK - EAR LOOP
4DISPOSABLE SURGICAL FACE MASKCHILDREN SURGICAL FACE MASK - HEAD LOOP
Back