BEUDAMED
    FDA Registration Active 🇨🇳 China

    Fingertip Pulse Oximeter M160C

    Reg #: 3018962549 · FEI: 3018962549 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD
    Registration Number
    3018962549
    FEI Number
    3018962549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone C, 4th Floor, F Building, Xinwei Second Industrial Zone Guangming District, Shenzhen, Guangdong 518106
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201384

    Owner / Operator

    Firm Name
    Shenzhen Raysintone Technology CO., Ltd
    Operator Number
    10081315
    Address
    Zone C, 4th Floor, F Building, Xinwei Second Industrial Zone Guangming District, Shenzhen, Guangdong 518106
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN
    Correspondent
    Xingbao Yang

    US Agent

    Business Name
    Humiss Inc.
    Contact Name
    James St WU
    Address
    1942 Broadway St., STE 314C, Boulder, CO, 80302, USA
    City
    Boulder
    State
    CO
    ZIP
    80302
    Country
    US
    Email
    [email protected]
    Phone
    720 7595888

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Fingertip Pulse Oximeter M160C Fingertip Pulse Oximeter M130B Fingertip Pulse Oximeter M230B Fingertip Pulse Oximeter M230A Fingertip Pulse Oximeter M230C Fingertip Pulse Oximeter M230 Fingertip Pulse Oximeter M160A Fingertip Pulse Oximeter M170C Fingertip Pulse Oximeter M130 Fingertip Pulse Oximeter M130C Fingertip Pulse Oximeter M130A Fingertip Pulse Oximeter M170A

    Establishment Types

    Manufacture Medical Device