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 DEVICEDURASAFE FACE MASK
ESTABLISHMENT NAMEPROMEDICTECH SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA8927523-128731
BRAND NAMEDURASAFE
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONDURASAFE 3 PLY MEDICAL FACE MASK
DEVICE INTENDED PURPOSEMedical 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 REGISTRATION18/04/2023 - 17/04/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1DURASAFE FACE MASKFM-EBDS3P
2DURASAFE FACE MASKFM-TBDS3P
3DURASAFE FACE MASKFM-EWDS3P
4DURASAFE CHILDREN FACE MASKFM-EP3PCB
5DURASAFE CHILDREN FACE MASKFM-EP3PCP