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 4PLY MEDICAL FACE MASK
ESTABLISHMENT NAMECONCEPT HERO SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA1224222-88199
BRAND NAMEAMDPRO+
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 PURPOSEMedical/Surgical mask is meant to help block large-particle droplet, splashes, sprays or splatter that contain germs (viruses and bacteria), keeping it from reaching your mount and nose. Surgical mask may also help reduce exposure of your saliva n respiratory secretions to others
VALIDITY DATE OF REGISTRATION18/03/2022 - 17/03/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1KF94 DISPOSABLE MEDICAL FACE MASK, 4PLYFM-AP+KF94-K-M-200
2KF94 DISPOSABLE MEDICAL FACE MASK, 4PLYFM-AP+KF94-M-220
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