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 DEVICEANTI-VIRAL FACE MASK
ESTABLISHMENT NAMEIDS MEDICAL SYSTEMS (M) SDN BHD
REGISTRATION NOGMD47677826618A
BRAND NAMERESPOKARE
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONRespoKare Anti-Viral Facemask is a single use disposable, flat-folded mask that pleated to expand into a concertina-shaped. The device intended use is to have a physical barrier to protect users from viruses, as well as a chemical layer, consist of a hydrophilic plastic coating on the outer layer containing 2% citric acid and a second inner layer treated with metal ions of copper and zinc, to inactivate virus upon contacting the mask.
DEVICE INTENDED PURPOSEthis is a fluid-resistant, single use, disposable face mask that actively kills 99.99% of the tested viruses. It helps reduce exposure to bodily fluids and particulate materials. It breaths well and provides all-day comfort.
VALIDITY DATE OF REGISTRATION01/10/2023 - 30/09/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Anti-Viral Mask-Adult-24pcsRK-200-2002A-301
2Anti-Viral Mask-Adults-1pcRK-200-2001A-301
3Anti-Viral Mask-Adults-5pcsRK-200-2001A-300
4Anti-Viral Mask-Adults-24pcsRK-200-2001A-319
5Anti-Viral Mask-Adults-30pcsRK-200-2001A-308
6Anti-Viral Mask-Child-1pcRK-200-3015A-301
7Anti-Viral Mask-Child-5pcsRK-200-3015A-300
8Anti-Viral Mask-Child-24pcsRK-200-3015A-319
9Anti-Viral Mask-Child-10pcsRK-200-2005A-310