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  • Medical Device Marketing Authorization: GHTF-2020-1914 3

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    FERAS ALSAMAK
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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 Ningbo Haishu Esco Medical Technology Co., Ltd. to market small steam sterilizers for sterilization equipment, surgical dressings, glassware, and injectors in Saudi Arabia. The medical devices are identified in an attached annex. The authorization is issued in accordance with Saudi Arabia's Medical Devices Law and expires on October 26, 2023.

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    305030_GHTF-2020-1914

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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 Ningbo Haishu Esco Medical Technology Co., Ltd. to market small steam sterilizers for sterilization equipment, surgical dressings, glassware, and injectors in Saudi Arabia. The medical devices are identified in an attached annex. The authorization is issued in accordance with Saudi Arabia's Medical Devices Law and expires on October 26, 2023.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    26 views1 page

    Medical Device Marketing Authorization: GHTF-2020-1914 3

    Uploaded by

    FERAS ALSAMAK
    This document is a medical device marketing authorization issued by the Executive Department of Medical Devices Evaluation in Saudi Arabia. It authorizes Ningbo Haishu Esco Medical Technology Co., Ltd. to market small steam sterilizers for sterilization equipment, surgical dressings, glassware, and injectors in Saudi Arabia. The medical devices are identified in an attached annex. The authorization is issued in accordance with Saudi Arabia's Medical Devices Law and expires on October 26, 2023.

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    © All Rights Reserved
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    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: 26/10/2020 Authorization Number: GHTF-2020-1914 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 18/12/1443 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬


    Expiry Date: 26/10/2023 Version Number: 3 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 11/4/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
    Last Version Date: 17/7/2022 18/12/1443 :‫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:


    ME0000018290 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

    NINGBO HAISHU ESCO MEDICAL TECHNOLOGY CO., LTD.


    Building 5,No.1 Jinhui Road, Hengjie Town, Haishu District,,315181 China

    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

    small steam sterilizers for sterilization equipment , surgical


    Medical Device Descrip tio n ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬
    dressing , glassware , injectors

    Medical Device Natio nal ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﺠ ﻬ ﺎ ز‬


    ME0000018290SFDAA00001
    Listing Numb er ‫ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟﻮ ﻃﻨ ﻲ‬

    Brand / Trade Name Steam Sterilizer ‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬

    ‫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.
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