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DEVICE DETAILS

NAME OF DEVICEFACE MASK
ESTABLISHMENT NAMEA R MEDICOM (M) SDN BHD
REGISTRATION NOGMD4546584017A
BRAND NAMEMedicom
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA single-use and non-sterile procedure masks that are intended to be worn by personnel during surgical or other medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer.
DEVICE INTENDED PURPOSEThe procedure masks are intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer.
VALIDITY DATE OF REGISTRATION01/01/2022 - 31/12/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Premier Earloop MaskSafe + Mask 2011M
2Premier Earloop MaskSafe + Mask 2015M
3Premier Earloop MaskSafe + Mask 2016M
4Premier Earloop MaskSafe + Mask 2018M
5Medicom Child MaskSafe + Mask 2115kid
6Tie-On MaskSafe + Mask 2000B
7Pro-Shield Earloop MaskSafe + Mask 2025-Earloop
8Pro-Shield Tie-on MaskSafe + Mask 2026 Tie-on
9Full Face ShieldSafe + Mask 2033
10Procedure Earloop Face MaskSafe + Mask-2120
11Premier Plus Level 2 Earloop Face MaskSafe + Mask 2027
12Premier Plus Level 2 Tie-On MaskSafe + Mask 2127
13Sof-Skin Earloop Mask (ASTM Level 1)Safe + Mask 2330
14Anti-Fog Tie-On Mask (ASTM Level 1)Safe + Mask 2050
15SFM Premier Elite Earloop Mask (ASTM Level 3)Premier Elite Mask GMK201915
16Pro-Lane Relax Individual Pack Earloop Mask (ASTM Level 3)Pro-Lane Relax GMK211014 (White)
17Pro-Lane Relax Individual Pack Earloop Mask (ASTM Level 3)Pro-Lane Relax GMK211015 (Blue)
18Pro-Lane Relax Individual Pack Earloop Mask (ASTM Level 3)Pro-Lane Relax GMK211016 (Pink)
19Defender Earloop Mask (ASTM Level 1)Safe + Mask 2111
20Defender Earloop Mask (ASTM Level 1)Safe + Mask 2114
21Defender Earloop Mask (ASTM Level 1)Safe + Mask 2115
22Defender Earloop Mask (ASTM Level 1)Safe + Mask 2116
23Defender Earloop Mask (ASTM Level 1)Safe + Mask 2117
24Defender Earloop Mask (ASTM Level 1)Safe + Mask 2118
25Premier Earloop Mask (ASTM Level 1)Safe + Mask PMRHMB2115
26Earloop Face Mask For Children (ASTM Level 1)Safe Mask GMK200015
27Face Mask For Kids (Age Under 6) (ASTM Level 1)Safe Mask SFMHMK2331
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