BEUDAMED
    FDA Registration Active 🇨🇳 China

    Pulse Oximeter (Model C101a2, C101b1, C101a3)

    Reg #: 3015007456 · FEI: 3015007456 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3015007456
    FEI Number
    3015007456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA.
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221979

    Owner / Operator

    Firm Name
    Shenzhen IMDK Medical Technology Co., Ltd.
    Operator Number
    10058601
    Address
    904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA.
    City
    SHENZHEN
    State
    Guangdong
    Postal Code
    518106
    Country
    CN
    Correspondent
    XIA YUAN

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Pulse Oximeter (Model C101a2, C101b1, C101a3)

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device