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 DEVICERespirator Face Mask - KF94 Face Mask
ESTABLISHMENT NAMERESPACK MEDICARE SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA3151221-66724
BRAND NAMERESPACK
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONRespirator Face masks are made of 4-ply of water resistant outer layer, non woven filter to filter out the dust and germs, excellent filtering melt blown fabric with electrostatic charge, soft and fine inner non woven skin friendly and suitable for sensitive skin. They have bacterial filtration efficiency and particles filtration efficiency for use by humans in any situation such as pandemic, medical sectors and common use for health concern.
DEVICE INTENDED PURPOSERespirator Face Mask is intended to be worn by Medical Personnel during surgical or other Medical Procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluid and particulate material transfer.
VALIDITY DATE OF REGISTRATION16/07/2021 - 15/07/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1Respirator Face Mask - KF94 Face MaskClass 1-Respack-Respirator Face Mask
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