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 DEVICEDisTech Earloop Face Mask
ESTABLISHMENT NAMEA R MEDICOM (M) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA4617522-103119
BRAND NAMEDisTech
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single-use and non-sterile procedure masks that are intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer.
DEVICE INTENDED PURPOSEThe procedure masks are intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer.
VALIDITY DATE OF REGISTRATION12/09/2022 - 11/09/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1DisTech Earloop Face MaskDIT0002114
2DisTech Earloop Face MaskDIT0002115
3DisTech Earloop Face MaskDIT0002116
4DisTech Earloop Face MaskDIT0002117
5DisTech Earloop Face MaskDIT0002118
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