Certification Body: DQS Malaysia, Suite 43-4 Setia Avenue, Jalan Setia Prima S U 13/S, Setia Alam Seksyen U 13, 40170 Shah Alam, Selangor - Malaysia 1 / 10
CERTIFICATE
This is to certify that
Welch Allyn Malaysia Sdn Bhd
Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
has implemented and maintains a Good Distribution Practice For Medical Devices.
Scope: Distribution, installation, and servicing and documentation of finished medical devices, systems, lighting products and associated components and accessories for use in gastroenterological and gynaecological endocospic procedures, cardiopulmonary assessment and interventation, acquiring and monitoring vital signs, monitoring systems and the examination and test of the eyes, ears, nose, throat and skin
Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard:
GDPMD (Edition: 1st July 2013)
Certificate registration no.
Date of certification
Valid until
50450076 GDPMD
2014-11-26
2017-11-25
DQS Certification (M) Sdn Bhd
Danny Ng Regional Managing Director
Welch Allyn Malaysia Sdn Bhd Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
This annex (edition:2014-11-26 ) is only valid in connection with the above-mentioned certificate.
List of devices dealt with by the establishment. No. Name of
medical device Manufacturer Brand/
Model Manufacturer product number/ code
Grouping (single/ family/ system/test kit/cluster)
Class GMDN Code
Medical device registration number
1 Welch Allyn CP150 Electrocardiograph
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
CP150 901049 Electro cardiograph
System B 16231 -
2 Welch Allyn CP50 Electrocardiograph
Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath Republic of Ireland
CP50 901048 Electrocardiograph
System B 16231 -
3
Welch Allyn CP 100 and CP 200 Electrocardiographs
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
CP100 CP200
CP1A- 4E2, CP2A- 4E2 Family B 16231 -
4 ProBP 3400
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
ProBP 3400 Series
34XXHT-4 34XXWT-4 34XXST-4 34XFHT-4 34XFWT-4 34XFST-4 34BFHT-4 34BFWT-4 34BFST-4
Family B 16173 -
5 Welch Allyn DS66 Durashock
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
5098-27 5098-27 Single A 16156 -
6 DuraShock Trigger Model DS65 - Silver Line
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
DS-6501-189 DS-6501-189 Single A 16156 -
7 DuraShock Hand Held Model DS54 - Bronze Line
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
DS-5401-189 DS-5401-189 Single A 16156 -
Welch Allyn Malaysia Sdn Bhd Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
This annex (edition:2014-11-26 ) is only valid in connection with the above-mentioned certificate.
No. Name of
medical device Manufacturer Brand/
Model Manufacturer product number/ code
Grouping (single/ family/ system/test kit/cluster)
Class GMDN Code
Medical device registration number
8 Digital Blood Pressure Meters (OSZ 5)
Microlife Corp. 9F, 431, RuiGuang Road, NeiHu Taipei 114, Taiwan, R.O.C.
OSZ 5 55-95-127 16-40-000 16-43-000
System B 16173 -
9 Wall and Mobile Sphygmomanometers
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
767 Series Desktop , Wall and Mobile Aneroid
7670-16 7670-01 7670-10
System A 16156 -
10 3.5V BI Diagnostic Set
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
97150-BIM 97150-BIM System A 12849 -
11
Digital MacroView Otoscope w/Specula Complete with Lithiun Ion Handle
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
Digital MacroViewTM Otoscope
23920 71904 System A 12849 -
12 GS Diagnostic Desk System
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
GS Diagnostic Desk System
77535-14 77535-34 77535-54
System A 17115 -
13 3.5v Ophthalmoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
11710 11710 System A 12817 -
14 3.5v Coaxial Ophthalmoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
11720 11720 System A 12817 -
Welch Allyn Malaysia Sdn Bhd Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
This annex (edition:2014-11-26 ) is only valid in connection with the above-mentioned certificate.
No. Name of medical device
Manufacturer Brand/ Model
Manufacturer product number/ code
Grouping (single/ family/ system/test kit/cluster)
Class GMDN Code
Medical device registration number
15 3.5v AutoStep Ophthalmoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
11730 11730 System A 12817 -
16 3.5v Finnoff Transilluminator
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
41100 41100 System A 12817 -
17 3.5v Finnoff Transilluminator with Cobalt Filter
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
41101 41101 System A 12817 -
18 3.5v Strabismoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
12400 12400 System A 12817 -
19 3.5v Prestige Coaxial-Plus Ophthalmoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
11735 11735 System A 12817 -
20 3.5v Diagnostic Otoscope/Throat Illuminator
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
20000 20000 System A 12849 -
21 3.5v Operating Otoscope with Specula
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
21700 21700 System A 12849 -
Welch Allyn Malaysia Sdn Bhd Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
This annex (edition:2014-11-26 ) is only valid in connection with the above-mentioned certificate.
No. Name of
medical device Manufacturer Brand/
Model Manufacturer product number/ code
Grouping (single/ family/ system/test kit/cluster)
Class GMDN Code Medical device registration number
22 3.5v Pneumatic Otoscope with Specula
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
20200 20200 System A 12849 -
23 3.5v Otoscope, 12 Diopter Lens with Specula
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
20250 20250 System A 12849 -
24
3.5v Halogen Diagnostic Otoscope with Specula
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
25020 25020 System A 12849 -
25 MacroView Diagnostic Otoscope
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
23810 23810 System A 12849 -
26
3.5v Throat Illuminator Section Only for 20000 (Snap On)
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
25257 25257 System A
36761 Light Transilluminator 12276 Light Examination
-
27
3.5v Bivalve Nasal Speculum with Throat Illuminator (23557)
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
26030 26030 System A
36762 Light Transilluminator 12276 Light Examination
-
28 3.5v Bivalve Nasal Speculum Only
Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 United States of America
26035 26035 System A
36763 Light Transilluminator 12276 Light Examination
-
Welch Allyn Malaysia Sdn Bhd Suite GF 101-2, Ground Floor, Tower 2, Wisma AmFIRST, Jalan SS7/15 ( Jalan Stadium), 47301, Kelana Jaya, Petaling Jaya, Selangor, Malaysia
This annex (edition:2014-11-26 ) is only valid in connection with the above-mentioned certificate.
No. Name of
medical devi