Executive Department of Medical

‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

Issuing Date: 20/10/2016 Authorization Number: GHTF-2016-2670 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 19/1/1438 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 19/10/2022 Version Number: 5 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 24/3/1444 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

The authorisation is issued in accordance with the Medical ‫أﺻﺪر ﻫﺬا اﻹذن ﺑﻤﻮﺟﺐ ﻻﺋﺤﺔ رﻗﺎﺑﺔ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ واﻟﻘﻮاﻋﺪ‬
devices interim regulation (MDIR) and in particular to the .‫ ( اﻟﺨﺎﺻﺔ ﺑﺈذن ﺗﺴﻮ ﻳﻖ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ‬MDS-IR6 ) ‫اﻻﺟﺮاﺋ ﻴﺔ‬
implementing rule MDS-IR6 for Medical Device Marketing
Authorisation (MDMA)

This authorization allows:

ME0000002083 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

Diatron MI Zrt
Tablas Street No. 39,Budapest,1097 Hungary

To market the medical devices listed in the attached annex* ‫ اﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ اﻟﻤﺤﺪدة ﻓﻲ اﻟﻘﺎﺋﻤﺔ اﻟﻤﺮﻓﻘﺔ* ﻓﻲ‬/ ‫ﺑﺘﺴﻮ ﻳﻖ اﻷﺟﻬﺰة‬
in the Kingdom of Saudi Arabia ‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑ ﻴﺔ اﻟﺴﻌﻮد ﻳﺔ‬

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 1 of 5
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation Medical Devices
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorisation

Issuing Date: 20/10/2016 Annex Number: GHTF-2016-2670 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/1/1438 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 19/10/2022 No. of Annex Pages: 5 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 24/3/1444 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

This annex is an integral part of the Medical Devices ‫ ﻣﻨﺘﺞ ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (GHTF-2 0 16 -2 6 70 ) ‫رﻗﻢ‬
Authorisation Number (GHTF-2016-2670) (5 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (5)

: Issued to ME0000002083 : ‫ا ﺻ ﺪر ت ل‬

Diatron MI Zrt

Tablas Street No. 39,Budapest,1097 Hungary

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟﻮ ﻃﻨ ﻲ‬

Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

1 Abacus 5 Automated Hematology Analyzer ME0000002083SFDAA00005

2 Abacus 380 Automated Hematology Analyzer ME0000002083SFDAA00006

3 Diatro•Lyse-DIFF Lysing Reagent for Automated Analysis on Hematology Analyzers ME0000002083SFDAA00008

4 Diatro•Cleaner Detergent solution for the removal of cellular debris on blood cell counters ME0000002083SFDAA00009

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.

Page 2 of 5
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation Medical Devices
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorisation

Issuing Date: 20/10/2016 Annex Number: GHTF-2016-2670 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/1/1438 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 19/10/2022 No. of Annex Pages: 5 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 24/3/1444 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

This annex is an integral part of the Medical Devices ‫ ﻣﻨﺘﺞ ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (GHTF-2 0 16 -2 6 70 ) ‫رﻗﻢ‬
Authorisation Number (GHTF-2016-2670) (5 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (5)

: Issued to ME0000002083 : ‫ا ﺻ ﺪر ت ل‬

Diatron MI Zrt

Tablas Street No. 39,Budapest,1097 Hungary

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟﻮ ﻃﻨ ﻲ‬

Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

5 Diatro•Clenz Enzymatic solution with proteolytic action for the cleaning of blood cell counter ME0000002083SFDAA00010

6 Diatro•Hypoclean Cleaning and bleaching solution for blood cell counters ME0000002083SFDAA00011

7 Diatro•Hypoclean CC Cleaning and bleaching Concentrate for blood cell counters ME0000002083SFDAA00012

8 Diatro•Dil-5P Buffered isotonic solution for blood cell counting ME0000002083SFDAA00013

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.

Page 3 of 5
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation Medical Devices
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorisation

Issuing Date: 20/10/2016 Annex Number: GHTF-2016-2670 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/1/1438 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 19/10/2022 No. of Annex Pages: 5 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 24/3/1444 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

This annex is an integral part of the Medical Devices ‫ ﻣﻨﺘﺞ ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (GHTF-2 0 16 -2 6 70 ) ‫رﻗﻢ‬
Authorisation Number (GHTF-2016-2670) (5 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (5)

: Issued to ME0000002083 : ‫ا ﺻ ﺪر ت ل‬

Diatron MI Zrt

Tablas Street No. 39,Budapest,1097 Hungary

‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ‬
‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬
‫ا ﻟﻮ ﻃﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n
Medical Natio nal Listing No .

Concentrated enzymatic solution with proteolytic action for the cleaning of blood
9 Diatro•Clenz CC ME0000002083SFDAA00014
cell counters

Diacon 3 Hematology
10 Controls for monitoring the performance of hematology blood cell counters ME0000002083SFDAA00015
Control

Diacon 5 Hematology
11 Controls for monitoring the performance of hematology blood cell counters ME0000002083SFDAA00016
Control

Diatrocal Hematology
12 calibrator to verify and adjust calibration of hematology analyzers ME0000002083SFDAA00017
Calibrator

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.

Page 4 of 5
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation Medical Devices
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorisation

Issuing Date: 20/10/2016 Annex Number: GHTF-2016-2670 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/1/1438 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 19/10/2022 No. of Annex Pages: 5 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 24/3/1444 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

This annex is an integral part of the Medical Devices ‫ ﻣﻨﺘﺞ ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (GHTF-2 0 16 -2 6 70 ) ‫رﻗﻢ‬
Authorisation Number (GHTF-2016-2670) (5 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (5)

: Issued to ME0000002083 : ‫ا ﺻ ﺪر ت ل‬

Diatron MI Zrt

Tablas Street No. 39,Budapest,1097 Hungary

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟﻮ ﻃﻨ ﻲ‬

Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

13 Diatro•Lyse-5P Lysing Reagent for Automated Analysis on Hematology Analyzers ME0000002083SFDAA00018

14 Diatro•Diff-5P Reagent for differentiation of leukocytes (WBC) subpopulations ME0000002083SFDAA00019

15 Diatro•Dil-DIFF Buffered isotonic solution for blood cell counting ME0000002083SFDAA00020

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.

Page 5 of 5