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 DEVICESURGICAL FACE MASK
ESTABLISHMENT NAMEJINGGA ANGGUN SDN BHD
ROLE OF ESTABLISHMENTMANUFACTURER
REGISTRATION NOGA6305621-78604
BRAND NAMEEMPRO
MEDICAL DEVICE CATEGORYSINGLE-USE DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMODEL : VS-913/MM-139/SM-8768/SM-149S/SM-149C/MS31-3P/GS-319/SK-3187 USA ASTM LEVEL 3 (HIGHEST) ASTM F2101-19 BACTERIAL FILTRATION EFFICIENCY: >=99.9% VIRAL FILTRATION EFFICIENCY>=99.9% PARTICLE FILTRATION EFFICIENCY : >= 98% FLUID RESISTANCE:>= 160mmHg BREATHABILITY -DELTA P:<6.0mmH20/cm2 FLAMMABILITY : CLASS 1 PRODUCT IS HYPOALLERGENIC,LATEX AND FIBERGLASS-FREE RECOMMENDED FOR SENSITIVE SKIN SOFT & LIGHTWEIGHT
DEVICE INTENDED PURPOSEThis product is intended for general purpose infection control practices. When properly worn, it reduces potential contact by the wearer to blood and bodily fluids
VALIDITY DATE OF REGISTRATION21/11/2021 - 20/11/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1SURGICAL FACE MASK (3PLY) -COPPER OXIDE MASKVS-913
2SURGICAL FACE MASK (3PLY) -COPPER OXIDE MASKSK-3187
3SURGICAL FACE MASK - M SERIESMM-139
4SURGICAL FACE MASK - S SERIESSM-8768
5SURGICAL FACE MASK - R SERIESSM-149C
6SURGICAL FACE MASK - C SERIESMS31-3P
7SURGICAL FACE MASK - G SERIESGS-319
8SURGICAL FACE MASK (3PLY) -COPPER OXIDE MASKTS-8778
9SURGICAL FACE MASK (3PLY) -COPPER OXIDE MASKPR-1991
10SURGICAL FACE MASK (3PLY) -COPPER OXIDE MASKRE3113
11Surgical Face Mask -S seriesSI-8768
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