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    FDA Registration Active 🇨🇳 China

    SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.

    Reg #: 3020924771 · FEI: 3020924771 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.
    Registration Number
    3020924771
    FEI Number
    3020924771
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park, Tianliao Community, Yutang Street, Guangming District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213431

    Owner / Operator

    Firm Name
    Shenzhen Witleaf Medical Electronics Co., Ltd.
    Operator Number
    10087479
    Address
    Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park, Tianliao Community, Yutang Street, Guangming District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518132
    Country
    CN

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Oximeter, Wellness PGJ
    Oximeter DQA
    Airway, Nasopharyngeal BTQ
    Oximeter, Infrared, Sporting, Aviation OCH

    Proprietary Names

    Handheld Pulse Oximeter CH-100; Wellness Oximeter Handheld Pulse Oximeter (model: WIT-S100, WIT-S300, CH-100B) Fingertip Pulse Oximeter (model: WIT-S200, WIT-S400) Nasopharyngeal airway for oxygenation and capnography (model: iway 13, iway 15) Pulse Oximeter (model: CH-100)

    Establishment Types

    Manufacture Medical Device