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: 22/12/2019 Authorization Number: GHTF-2019-6013 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 25/4/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 11/6/2024 Version Number: 9 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 05/12/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 11/6/2021 02/11/1442 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

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:

ME0000012764 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

Epocal Inc. (a Siemens Healthineers Company)

2060 Walkley Road,Ottawa,K1G3P5 Canada

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 2
 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: 22/12/2019 Annex Number: GHTF-2019-6013 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 25/4/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 11/6/2024 No. of Annex Pages: 2 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 05/12/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 11/6/2021 11/6/2021 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

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 19 -6 0 13 ) ‫رﻗﻢ‬
Authorisation Number (GHTF-2019-6013) (9 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (9)

: Issued to ME0000012764 : ‫ا ﺻ ﺪر ت ل‬

(Epocal Inc. (a Siemens Healthineers Company

Walkley Road,Ottawa,K1G3P5 Canada 2060

‫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 .

Acquisition unit for receiving raw signals and converting to transmittable

1 epoc Blood Analysis / Epoc Reader ME0000012764SFDAA00001
format.

2 epoc Blood Analysis / epoc Host 2 User interface for displaying test results. ME0000012764SFDAA00002

epoc Blood Analysis / BGEM Test

3 Single-use device with port for blood sample introduction ME0000012764SFDAA00003
Cards

4 epoc NXS Host User interface module ME0000012764SFDAA00316

‫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 2