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 DEVICEFace Mask
ESTABLISHMENT NAMEDARREN DENTAL SUPPLY SDN BHD
REGISTRATION NOGA8145423-146360
BRAND NAMEInternational Orthodontic Services
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONA facemask is an appliance used in orthodontic treatment to correct cases with midfacial deficiency, CLP and similar cases.
DEVICE INTENDED PURPOSEA dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.
VALIDITY DATE OF REGISTRATION29/08/2023 - 28/08/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Face Mask Clear16-111-100
2Face Mask Blue16-111-101
3Face Mask Teal16-111-102
4Face Mask Pearl16-111-103
5Face Mask Red16-111-104
6Face Mask American Flag16-111-105
7Face Mask Hawaii16-111-106
8Face Mask Racin's Flames16-111-107
9Face Mask Tiger16-111-108
10Face Mask Pad Replacment - Clear16-112-100
11Face Mask Pad Replacment - American Flag16-112-105
12Face Mask Pad Replacment - Hawaii16-112-106
13Face Mask Pad Replacment - Racin' Flames16-112-107
14Face Mask Pad Replacment - Tiger16-112-108
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