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 DEVICENASAL MASK / NASAL PILLOWS INTERFACE / FULL FACE MASK
ESTABLISHMENT NAMEROCKY SCIENTIFIC INSTRUMENTATION
REGISTRATION NOGB10318220-46798
BRAND NAMEBMC
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONMask covers patient’s nose while the adjustable headgear straps hold the mask in place. Headgear Straps that are too loose permit air to leak while too tights traps can break the seal and create leaks; any strap pulled too tightly can cause discomfort. Headgear straps are snug enough for a good fit in all sleeping positions (side and front) but not tight. The straps loop into the hooks on the frame, and they both allow for quick, easy removal of the mask.
DEVICE INTENDED PURPOSEThe Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Mask is: - to be used by adult patients (> 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.
VALIDITY DATE OF REGISTRATION08/09/2020 - 07/09/2025

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1BMC-NM2 Nasal Mask10020020
2BMC-NM2 Nasal Mask10020018
3BMC-NM2 Nasal Mask10020019
4NM4 Nasal Mask10020107
5NM4 Nasal Mask10020108
6NM4 Nasal Mask10020109
7N5 Nasal Mask10020180
8N5 Nasal Mask10020179
9N5 Nasal Mask10020178
10N5 Nasal Mask10020334
11N5A Nasal Mask10020195
12N5A Nasal Mask10020194
13N5A Nasal Mask10020193
14N5A Nasal Mask10020335
15P2 Nasal Pillows Interface10010030
16BMC-FM1A Full Face Mask10030127
17BMC-FM1A Full Face Mask10030128
18BMC-FM1A Full Face Mask10030129
19BMC-FM2 Full Face Mask10030100
20BMC-FM2 Full Face Mask10030101
21BMC-FM2 Full Face Mask10030102
22F1B Full Face Mask10030163
23F1B Full Face Mask10030164
24F1B Full Face Mask10030165
25F5 Full Face Mask10030358
26F5 Full Face Mask10030357
27F5 Full Face Mask10030356
28F5A Full Face Mask10030324
29F5A Full Face Mask10030323
30F5A Full Face Mask10030322
31N5H Nasal Mask10020358
32N5H Nasal Mask10020359
33N5H Nasal Mask10020360
34N5H Nasal Mask10020361
35N5AH Nasal Mask10020370
36N5AH Nasal Mask10020371
37N5AH Nasal Mask10020372
38N5AH Nasal Mask10020373
39P2H Nasal Pillows Interface10020391
40Nasal Mask(N6)10020662 S
41Nasal Mask(N6)10020663 M
42Nasal Mask(N6)10020664 L
43Nasal Mask(N6)10020660（All Size Kit）
44Nasal Pillows Interface (P6)10010069
45Full Face Mask (F6)10030754 S
46Full Face Mask (F6)10030753 M
47Full Face Mask (F6)10030752 L
48Full Face Mask (F6)10030756（All Size Kit）
49Nasal Mask (N5+)10020754 S
50Nasal Mask (N5+)10020753 M
51Nasal Mask (N5+)10020754 L
52Nasal Mask (N5+)10020756（ All Size Kit）
53Nasal Mask (N5A+)10020635 S
54Nasal Mask (N5A+)10020634 M
55Nasal Mask (N5A+)10020633 L
56Nasal Mask (N5A+)10020636（ All Size Kit）
57Full Face Mask (F5+)10030841 S
58Full Face Mask (F5+)10030840 M
59Full Face Mask (F5+)10030839 L
60Full Face Mask (F5+)10030842（ All Size Kit）
61Full Face Mask (F5A+)10030849 S
62Full Face Mask (F5A+)10030848 M
63Full Face Mask (F5A+)10030847 L
64Full Face Mask (F5A+)10030850（All Size Kit）
65Nasal Mask(N5)10020202（All Size Kit）
66Nasal Mask(N5A)10020273（All Size Kit）
67Full Face Mask(F5)10030371（All Size Kit）
68Full Face Mask(F5A)10030378（All Size Kit）
Back