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.


DEVICE DETAILS

NAME OF DEVICEEsential KF94 Face Mask
ESTABLISHMENT NAMEMAXWELL MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA1623422-92532
BRAND NAMEEsential
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONEsential KF94 face masks are made of 4-ply of water-resistant outer layer, non-woven filter to filter out microorganisms and dust, excellent filtering melt-blown fabric with electrostatic charge, soft and fine inner non-woven skin-friendly, and suitable for sensitive skin. Suitable for use in situations like a pandemic, medical sectors, and common use for health concerns.
DEVICE INTENDED PURPOSETo be used by medical personnel during surgical or other medical procedures in order to protect both the patient and the operating personnel from the transfer of microorganisms, body fluid, and particulate material transfer.
VALIDITY DATE OF REGISTRATION17/05/2022 - 16/05/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Esential KF94 Face Mask (Black)0762983188204
2Esential KF94 Face Mask (Blue)0762983188198
3Esential KF94 Face Mask (Grey)0762983188181
4Esential KF94 Face Mask (Pink)0762983188174