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    Au480 230828 123825

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    This document is a medical device marketing authorization issued by the Executive Department of Medical Devices Evaluation in Saudi Arabia. It authorizes Beckman Coulter, Inc. to market three automated clinical chemistry analyzers in the country. The authorization is issued in accordance with the country's Medical Devices Law and is valid until May 2024. An attached annex lists the three approved devices and their product descriptions and national listing numbers.

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    Au480 230828 123825

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    This document is a medical device marketing authorization issued by the Executive Department of Medical Devices Evaluation in Saudi Arabia. It authorizes Beckman Coulter, Inc. to market three automated clinical chemistry analyzers in the country. The authorization is issued in accordance with the country's Medical Devices Law and is valid until May 2024. An attached annex lists the three approved devices and their product descriptions and national listing numbers.

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    AU480_230828_123825

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    This document is a medical device marketing authorization issued by the Executive Department of Medical Devices Evaluation in Saudi Arabia. It authorizes Beckman Coulter, Inc. to market three automated clinical chemistry analyzers in the country. The authorization is issued in accordance with the country's Medical Devices Law and is valid until May 2024. An attached annex lists the three approved devices and their product descriptions and national listing numbers.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    23 views2 pages

    Au480 230828 123825

    Uploaded by

    8f4rvb2ssg
    This document is a medical device marketing authorization issued by the Executive Department of Medical Devices Evaluation in Saudi Arabia. It authorizes Beckman Coulter, Inc. to market three automated clinical chemistry analyzers in the country. The authorization is issued in accordance with the country's Medical Devices Law and is valid until May 2024. An attached annex lists the three approved devices and their product descriptions and national listing numbers.

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    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
    ‫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: 13/1/2019 Authorization Number: MDMA-1-2019-3953 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 07/5/1440 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬


    Expiry Date: 27/5/2024 Version Number: 8 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 20/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
    Last Version Date: 21/1/2022 18/6/1443 :‫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:


    ME0000014 865 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

    Beckman Coulter, Inc.


    250 S. Kraemer Blvd.,Brea, California,92821 United States

    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 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
    ‫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: 13/1/2019 Annex Number: MDMA-1-2019-3953 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 07/5/1440 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬


    Expiry Date: 27/5/2024 No. of Annex Pages: 2 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 20/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
    Last Version Date: 21/1/2022 21/1/2022 :‫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 19 -39 5 3 ) ‫رﻗﻢ‬
    Authorization Number (MDMA-1-2019-3953) (8 ) ‫ورﻗﻢ إﺻﺪار‬
    Issuing Number (8)

    : Issued to ME0000014865 : ‫ا ﺻ ﺪر ت ل‬

    .Beckman Coulter, Inc

    S. Kraemer Blvd.,Brea, California,92821 United States 250

    ‫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 BECKMAN COULTER CHEMISTRY ANALYZER AU480 Automated Clinical Chemistry Analyzer ME0000008377SFDAA00010

    2 BECKMAN COULTER CHEMISTRY ANALYZER AU680 Automated Clinical Chemistry Analyzer ME0000008377SFDAA00012

    3 BECKMAN COULTER CHEMISTRY ANALYZER AU580... Automated Clinical Chemistry Analyzer ME0000008377SFDAA00014

    ‫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

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