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 DEVICEMEDICAL FACE MASK
ESTABLISHMENT NAMEEPSILON MEDICAL DEVICES SDN BHD
REGISTRATION NOGA6395720-49447
BRAND NAMEEpsilon
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONMedical face masks are rectangular in shape and consist of a mask, nose clamp and an ear loops. The face masks covers the mouth and nose providing a barrier to minimize the direct transmission of infective agents. The mask consist of three layer and each layer comprises of fine to very fine fibres manufactured from non-woven materials (e.g. polypropylene, polyethylene or cellulose). The medical face mask provide high filtration, excellent breathability and fluid resistance. The use of medical face masks in the community may divert this critical resource from the healthcare professionals (in an operating room or other medical settings) and others who need them the most. The medical face mask is for single use only.
DEVICE INTENDED PURPOSEMedical face mask used to protect the user from transmission of infective agents and in some circumstances protect user against splashes of potentially contaminated liquids. Medical face masks may also be intended to be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations.
VALIDITY DATE OF REGISTRATION12/11/2020 - 11/11/2025

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1MEDICAL FACE MASKFGFMA001