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 NOGA5161323-153377
BRAND NAMEFace Mask
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMedical face mask, single-use.
DEVICE INTENDED PURPOSETo be worn to protect both the patient and healthcare personnel from the 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 REGISTRATION17/11/2023 - 16/11/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Bergamot 4-Ply Face Mask (Ear Loop)B0504
2Bergamot 4-Ply Vanscent Face Mask (Ear Loop)VS8011
3Bergamot Copper X 4-Ply Medical Face Mask (Earloop)XV613
4Bergamot 4-Ply Medical Face Mask (Earloop)BV612-AG
5Bergamot 4-Ply Medical Face Mask (Earloop)BV612-GN
6Bergamot 4-Ply Medical Face Mask (Earloop)BV612-PK
7Bergamot 4-Ply Medical Face Mask (Earloop)BV612-VT
8Bergamot 4-Ply Medical Face Mask (Earloop)BV612-YL
9Bergamot Cool Series Cordial Bears 4-Ply Medical Adults Face Mask (Earloop)B05-CB-A05
10Bergamot Cool Series Cordial Bears 4-Ply Medical Kids Face Mask (Earloop)B05-CB-K05
11Bergamot 4-Ply Medical Adults Face Mask (Earloop)B0521A
12Bergamot 4-Ply Medical Kids Face Mask (Earloop)B0521K
13Bergamot Vibrant 4-Ply Medical Adults Face Mask (Earloop)BV612