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 DEVICEULTRA FACE MASKS
ESTABLISHMENT NAMECANTEL MEDICAL (MALAYSIA) SDN. BHD.
REGISTRATION NOGMD8519912116A
BRAND NAMEULTRA
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONASTM Level 3 face mask with fluid resistant outer layer, soft tissue inner layer and extra long nose piece.
DEVICE INTENDED PURPOSECrosstex surgical masks are intended for the use in infection control practices to minimuze contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
VALIDITY DATE OF REGISTRATION14/09/2021 - 13/09/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Ultra® EarloopGCFCXU
2Ultra® Earloop w/SecureFit® TechnologyGCFCXUSF
3Ultra® FogFree EarloopGCFCX
4Ultra® FogFree Earloop w/ShieldGCPW
5Ultra® Sensitive EarloopGCFCXS
6Ultra® Sensitive FogFree EarloopGCFCXSF
7Ultra® Sensitive FogFree Earloop w/ShieldGCPWS
8Ultra® Sensitive Earloop w/SecureFit® TechnologyGCFCXSSF
9Ultra® Sensitive FogFree Earloop w/SecureFit® TechnologyGCFCXSFSF
10Ultra® Sensitive FogFree Earloop w/Shield w/SecureFit® TechnologyGCPWSSF
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