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