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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

Issuing Date: 15/11/2019 Authorization Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 Version Number: 11 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 18/7/1444 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

The Authorization is issued in accordance with the Medical ‫أﺻﺪر ﻫﺬا اﻹذن ﺑﻤﻮﺟﺐ ﻧﻈﺎم اﻷﺟﻬﺰة واﻟﻤﺴﺘﻠﺰﻣﺎت اﻟﻄﺒ ﻴﺔ اﻟﺼﺎدر‬
Devices Law issued by Royal Decree No. (M/54 ) dated .‫ ﻫـ‬6/7/1442 ‫ ( وﺗﺎر ﻳﺦ‬54/‫ﺑﺎﻟﻤﺮﺳﻮم اﻟﻤﻠﻜﻲ رﻗﻢ )م‬
6/7/14 4 2 HA,

This authorization allows:

ME0000006565 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 2354 2 Lubeck,Lubeck,2354 2 Germany

To market the medical devices listed in the attached annex* *‫ اﻟﻤﺴﺘﻠﺰﻣﺎت اﻟﻄﺒ ﻴﺔ اﻟﻤﺤﺪدة ﻓﻲ اﻟﻘﺎﺋﻤﺔ اﻟﻤﺮﻓﻘﺔ‬/ ‫ﺑﺘﺴﻮ ﻳﻖ اﻷﺟﻬﺰة‬
in the Kingdom of Saudi Arabia ‫ﻓﻲ 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 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م 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 Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

1 Oxylog VE300 Emergency care Ventilator ME0000006567SFDAA00180

2 Workstation Critical Care Intensive Care Ventilator ME0000006567SFDAA00148

3 Workstation NC Intensive Care Ventilator ME0000006567SFDAA00149

4 Savina 300 , system Intensive Care Ventilator ME0000006567SFDAA00150

‫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 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م 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 Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

5 Savina system Intensive Care Ventilator ME0000006567SFDAA00151

6 Babylog 8000 plus Intensive Care Ventilator ME0000006567SFDAA00152

7 Carina Sub-Acute Care Ventilator ME0000006567SFDAA00043

8 Evita V300 Intensive Care Ventilator ME0000006567SFDAA00153

‫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 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م 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 Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

9 Oxylog 1000 Emergency Care Ventilator ME0000006567SFDAA00155

10 Oxylog 2000 plus Emergency and transport Ventilator ME0000006567SFDAA00154

11 Oxylog 3000 plus Emergency care Ventilator ME0000006567SFDAA00156

12 Aquapor H300 Respiratory gas humidifier, connected between the therapy device and patients. ME0000006565SFDAA00025

‫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 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

1 H300 Heater wire adapter H300 hose heater adapter A1ME0000006565SFDAA00025

2 VentStar Aquapor Heated disposable breathing circuit A2ME0000006565SFDAA00025

3 Expiratory Hose Extension Expiration Hose Extension A3ME0000006565SFDAA00025

4 T-piece N T piece connector A4ME0000006565SFDAA00025

‫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 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

5 disposable exp. valve Carina Expiration Valve A1ME0000006567SFDAA00043

6 VentStar Carina ExpV Expiration Valve A2ME0000006567SFDAA00043

7 VentStar Resuscitaire infant care unit A3ME0000006567SFDAA00043

8 SyncVent Carina breathing phase control A4ME0000006567SFDAA00043

‫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 6 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

9 M14.5, Variant C500 DISPLAY DATA A1ME0000006567SFDAA00148

10 Evita V500 Ventilation Unit Ventilation Unit A2ME0000006567SFDAA00148

11 Disposable CO2 Cuvette CO2 mainstream measurement A3ME0000006567SFDAA00148

12 ID_Expiration valve disposable expiration valves A4ME0000006567SFDAA00148

‫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 7 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

13 Expiratory Filter Filter A5ME0000006567SFDAA00148

14 Double adapter 22/22 Adaptor, connector A6ME0000006567SFDAA00148

15 Ventilation neonatal Unit ventilation unit A1ME0000006567SFDAA00149

16 Expiration valve disposable expiration valves A1ME0000006567SFDAA00150

‫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 8 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

17 CO2-sensor Savina 300 Sensor A2ME0000006567SFDAA00150

18 Temperature sensor Sensor A3ME0000006567SFDAA00150

19 Disposable Expiration Valve savina disposable expiration valves A4ME0000006567SFDAA00150

20 Pneum. Medication Nebulizer N drug delivery device A1ME0000006567SFDAA00152

‫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 9 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

21 Expiration Valve Valve A2ME0000006567SFDAA00152

22 filter Cartridge Filter A3ME0000006567SFDAA00152

23 Expiration Valve Evita Expiration valve A1ME0000006567SFDAA00153

24 Evita V300 ,Ventilation unit Ventilation Unit A2ME0000006567SFDAA00153

‫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 10 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

25 ExpV Evita WT Expiration valve A3ME0000006567SFDAA00153

26 Connectivity Converter CC300 Connectivity Converter A4ME0000006567SFDAA00153

27 SoundEar plug power supply Power Supply A5ME0000006567SFDAA00153

28 PS500 LifePO4 Battery for Evita V300 A6ME0000006567SFDAA00153

‫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 11 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

29 Oxylog hose 2000f/3000f Breathing hose A1ME0000006567SFDAA00154

30 Breathing Valve Valve A2ME0000006567SFDAA00154

31 Flow sensor Flow sensor A3ME0000006567SFDAA00154

32 VentStar Oxylog Ventilation hose A4ME0000006567SFDAA00154

‫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 12 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

33 VentStar Oxylog 2000, 180 x5 Ventilation hose A5ME0000006567SFDAA00154

34 VentStar Oxylog3000F,2000p 150 Breathing circuit A6ME0000006567SFDAA00154

35 Test lung Test lung for equipment check A1ME0000006567SFDAA00155

36 Breathing tube Ventilation hose A2ME0000006567SFDAA00155

‫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 13 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

37 Breathing valve Valve A3ME0000006567SFDAA00155

38 Ventstar Oxylog 1000 180 x25 Reusable ventilation hose A4ME0000006567SFDAA00155

39 Breathing hose 22/22 (A) 300 ventilation hose A5ME0000006567SFDAA00155

40 Alduk Pressure Regulator A1ME0000006567SFDAA00156

‫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 14 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

41 AOS Automatic Oxygen Switch A2ME0000006567SFDAA00156

42 PSS300 Power socket strip PSS300 A3ME0000006567SFDAA00156

43 VentStar Oxylog VE300 Disposable breathing circuit A1ME0000006567SFDAA00180

44 Hose Oxylog VE300 Connector A2ME0000006567SFDAA00180

‫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 15 of 16
 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 ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 15/11/2019 Annex Number: MDMA-1-2017-2023 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 18/3/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 16 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 08/2/2023 08/2/2023 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 17-2 0 2 3 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2017-2023) (11 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (11)

: Issued to ME0000006565 : ‫ا ﺻ ﺪر ت ل‬

Dragerwerk AG & Co. KGaA

Moislinger Allee 53-55 , 23542 Lubeck,Lubeck,23542 Germany

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

45 Connector pressure OxylogVE300 Connector A3ME0000006567SFDAA00180

‫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 16 of 16