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.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICERESPIRATORY FACE MASKS (BITRAC NIC SELECT, BITRAC SHIELD, MAXSHIELD MASKS & ACCESSORIES) (LIST OF MEDICAL DEVICE AS LISTED IN ANNEX I)
ESTABLISHMENT NAMEGOODLABS MEDICAL (M) SDN BHD
REGISTRATION NOGB2839720-38836
BRAND NAMEPULMODYNE
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONRespiratory Face Masks are intended for single patient use and are provided clean, non‐sterile. The face mask family comes in a variety of sizes and styles to meet user preference. In addition to offering different sizes and cushion styles of masks, we also include headgear, and forehead pads. The masks provide a seal so that positive pressure from a positive pressure source is directed to the patient’s face/nasal area. It is held in place with an adjustable headgear system.
DEVICE INTENDED PURPOSEThe BiTrac Full Face mask is an accessory for use with CPAP or Bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilator support
VALIDITY DATE OF REGISTRATION28/11/2019 - 27/11/2024

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1BiTrac Select Full Face Mask313‐9543
2BiTrac Select Full Face Mask313‐9542
3BiTrac Select Full Face Mask313‐9541
4BiTrac Select Full Face Mask313‐9548
5BiTrac Select Full Face Mask313‐9547
6BiTrac Select Full Face Mask313‐9546
7BiTrac Select Full Face Mask313‐9048W
8BiTrac Select Full Face Mask313‐9047W
9BiTrac Select Full Face Mask313‐9046W
10BiTrac Select Full Face Mask313‐9044W
11BiTrac Select Full Face Mask313‐9043W
12BiTrac Select Full Face Mask313‐9042W
13BiTrac Select Full Face Mask313‐9573
14BiTrac Select Full Face Mask313‐9572
15BiTrac Select Full Face Mask313‐9571
16BiTrac Select Nasal Mask313‐9049W
17BiTrac Select Nasal Mask313‐9041W
18BiTrac Select Nasal Mask313‐9040W
19BiTrac Select MaxShield Mask313‐9555
20BiTrac Select MaxShield Mask313‐9556
21BiTrac Select MaxShield Mask313‐9552
22BiTrac Select MaxShield Mask313‐9554
23BiTrac Select MaxShield Mask313‐9553
24BiTrac Select MaxShield Mask313‐9551
25BiTrac MaxShield Mask313‐9052W
26BiTrac MaxShield Mask313‐9054W
27BiTrac MaxShield Mask313‐9053W
28BiTrac MaxShield Mask313‐9055W
29BiTrac Shield Mask313‐9050W
30BiTrac Shield Mask313‐9051W
31BiTrac Select MaxShield Mask313‐9526
32BiTrac Select MaxShield Mask313‐9527
33BiTrac Select MaxShield Mask313‐9524
34BiTrac Select MaxShield Mask313‐9525
35BiTrac SE Select Interchangeable Standard Elbow313‐9599
36BiTrac Select Interchangeable Anti‐ Asphyxia Elbow313‐9598
37BiTrac SE Select Interchangeable Standard Bronchoscopy Elbow313‐9597
38BiTrac Select Interchangeable Anti‐ Asphyxia Bronchoscopy Elbow313‐9596
39BiTrac SE Select Interchangeable Nebulizer Elbow313‐9595
40BiTrac Select Interchangeable Anti‐ Asphyxia Nebulizer Elbow313‐9594
41BiTrac Select Interchangeable Anti‐ Asphyxia w/Leak Elbow Size313‐9593
42BiTrac SE Select Pediatric Standard Elbow313‐9601
43BiTrac Select Pediatric Anti‐ Asphyxia w/Leak Elbow313‐9602
44BiTrac Select Interchangeable Anti‐ Asphyxia w/Leak Elbow Size313‐9593‐A
Back