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 DEVICEKF94 3D 4PLY FACE MASK
ESTABLISHMENT NAMECONCEPT HERO SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA9609922-89331
BRAND NAMEW+MEDTRONIC
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe 4 ply surgical mask with an added extra layer with one more filtering layer. They also have adjustable nose strip to give maximum protection and comfort to the user. With an added extra layer ensuring that you remain protected with 98% bacterial and particle filtration. A melt blown layer is critical as a filter because it provides a layer that contains droplets by electrostatically absorbing them on the surface. This makes it so that dust, particles, and bacteria cannot infiltrate the mask.
DEVICE INTENDED PURPOSEFluid resistant and provides the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids. Protects the patient from the wearer’s respiratory emissions. To be used as a barrier to prevent air-borne transfer of bacteria and particles. It is designed to be use in hospital, dental clinic, operating theater and etc especially by the surgeon / doctors / Nurse and the patient .
VALIDITY DATE OF REGISTRATION04/04/2022 - 03/04/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94 Disposable 3D 4ply Face Mask FM-KF94-W+-M-200
2KF94 Disposable 3D 4ply Face Mask FM-KF94-W+-M-220
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