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 DEVICEARMOUR 3PLY MEDICAL FACE MASK ULTRA THIN V-SHAPE 3D FACE MASK
ESTABLISHMENT NAMESYMBION ASIA SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA6957522-98909
BRAND NAME SYMBION
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONSurgical Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a melt-blown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via ear-loops or ties. Ear-loops ate of urethane elastic fibre and latex-free; and ties are of spun-bond polypropylene and also latex-free. The nose piece is a pliable white aluminium strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.
DEVICE INTENDED PURPOSESurgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
VALIDITY DATE OF REGISTRATION01/08/2022 - 31/07/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1ARMOUR 3PLY MEDICAL FACE MASK ULTRA THIN V-SHAPE 3D FACE MASK3PLY MEDICAL FACE MASK ULTRA THIN V-SHAPE 3D FACE MASK
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