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 DEVICEFace Mask
ESTABLISHMENT NAMEBERGAMOT SDN BHD
REGISTRATION NOGA3628622-111965
BRAND NAMEHalo
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMedical face mask, single-use
DEVICE INTENDED PURPOSETo be placed over the mouth and nose of a healthcare personnel to protect both the patient and healthcare personnel from transfer of microorganisms, particulate material, blood and body fluids. These face masks are not intended for surgical operation
VALIDITY DATE OF REGISTRATION16/12/2022 - 15/12/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Halo KF94 4-Ply Face Mask Negative Oxygen Ion (Earloop)OV315
2Halo KF94 4-Ply Face Mask Negative Oxygen Ion (Headloop)OV325
3Halo Coloured KF94 4-Ply Face Mask (Earloop)OV335
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