BEUDAMED
    FDA Registration Active 🇨🇳 China

    Pulse Oximeter

    Reg #: 3012777736 · FEI: 3012777736 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EMSRUN GROUP
    Registration Number
    3012777736
    FEI Number
    3012777736
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8-7 Huide Road, Huishan Area
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K173123

    Owner / Operator

    Firm Name
    EMSRUN GROUP
    Operator Number
    10052960
    Address
    8-7 Huide Road, Huishan Area
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214000
    Country
    CN
    Correspondent
    Weifeng Li

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Pulse Oximeter

    Establishment Types

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