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 DEVICEFace Mask
ESTABLISHMENT NAMEBERGAMOT SDN BHD
REGISTRATION NOGA4308421-58036
BRAND NAMEBergamot
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONTo be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile
DEVICE INTENDED PURPOSETo be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile
VALIDITY DATE OF REGISTRATION30/03/2021 - 29/03/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Bergamot 3-Ply Face Mask (Ear Loop)B0501
2Bergamot 3-Ply Face Mask (Tie On)B0502
3Bergamot 3-Ply Face Mask (Head Loop)B0507
4Bergamot 3-Ply Face Mask Basic Medical (Ear Loop)B0519
5Bergamot 4-Ply Face Mask (Ear Loop)B0504
6Bergamot 4-Ply Vanscent Face Mask (Ear Loop)VS8011
7Bergamot Copper X 4-Ply Medical Face Mask (Earloop)XV613
8Bergamot 3-Ply Medical Kids Face Mask (Earloop)B0518
9Bergamot 4-Ply Medical Face Mask (Earloop)BV612-AG
10Bergamot 4-Ply Medical Face Mask (Earloop)BV612-GN
11Bergamot 4-Ply Medical Face Mask (Earloop)BV612-PK
12Bergamot 4-Ply Medical Face Mask (Earloop)BV612-VT
13Bergamot 4-Ply Medical Face Mask (Earloop)BV612-YL
14Bergamot Cool Series Cordial Bears 4-Ply Medical Adults Face Mask (Earloop)B05-CB-A05
15Bergamot Cool Series Cordial Bears 4-Ply Medical Kids Face Mask (Earloop)B05-CB-K05