BEUDAMED
    FDA Registration Active 🇨🇳 China

    SS series reusable Spo2 sensors and SSD series disposable sensors

    Reg #: 3013783488 · FEI: 3013783488 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORANTECH INC.
    Registration Number
    3013783488
    FEI Number
    3013783488
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181270

    Owner / Operator

    Firm Name
    Orantech Inc.
    Operator Number
    10058634
    Address
    Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN
    Correspondent
    Yuanlan Zeng

    US Agent

    Business Name
    Medten USA Inc.
    Contact Name
    Andres Orjuela
    Address
    1 Technology Dr. Suite B115 Irvine, CA 92618
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    925 3599115

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    SS series reusable Spo2 sensors and SSD series disposable sensors

    Establishment Types

    Manufacture Medical Device