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 DEVICE4-Ply Premium Face Mask
ESTABLISHMENT NAMEHIL MEDIC SDN. BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA5329521-76076
BRAND NAMEHIL Medic
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONIt is a Non-woven Mask which meets all current ASTM F2100 level 3 and EN 14683 IIR standards for face masks. Used to cover the mouth and nose. They serve as a barrier for contaminants from getting released from the mouth of a sick person and spread to the environment, it suitable for use for surgical procedures purpose or by people in the public
DEVICE INTENDED PURPOSETo be used to protect both the users from transfer of microorganisms, body fluids, and particulate material.
VALIDITY DATE OF REGISTRATION15/10/2021 - 14/10/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
14 Ply Premium Face MaskFM005/01 - Colours
24 Ply Premium Face MaskFM005/02 - Pattern
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