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.


DEVICE DETAILS

NAME OF DEVICE3 Ply Surgical Face Mask - Tie On
ESTABLISHMENT NAMEASPEN ANGKASA SDN BHD
REGISTRATION NOGA5748522-96062
BRAND NAMEMcDICA
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe mask provides a physical barrier to block pollutants from nose and mouth and to reduce risks of spreading viruses and breathing in airborne particles. • Face Seal Fit (Loose-Fitting). • No Fit-Testing Requirement. • Does not provide the wearer with a reliable level of protection from inhaling smaller airborne particles and is NOT considered respiratory protection.
DEVICE INTENDED PURPOSEThe mask with hygiene barrier property is intended to be worn by doctor, nurse, and patient to cover the user's nose and mouth.
VALIDITY DATE OF REGISTRATION27/06/2022 - 26/06/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
13PLY SURGICAL FACE MASK TIE-ONMcDICA
23PLY SURGICAL FACE MASK TIE-ONMcDICA
33PLY SURGICAL FACE MASK TIE-ONMcDICA