BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY

    Reg #: 3016587556 · FEI: 3016587556 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY
    Registration Number
    3016587556
    FEI Number
    3016587556
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town
    City
    Zhongshan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K252669

    Owner / Operator

    Firm Name
    Zhongshan XiaoLan Town SenLan Electronic Factory
    Operator Number
    10082358
    Address
    2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town, Zhongshan City
    City
    Zhongshan City
    State
    Guangdong
    Postal Code
    528415
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction, Prescription ESD
    Hearing Aid, Air-Conduction, Over The Counter QUF
    Monitor, Ultrasonic, Fetal KNG
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG

    Proprietary Names

    HEARING AIDS A-130B;A-208B;F-135B;F-136B;F-138TB;F-139B;F-998B;V-168B;K-100;K-108;K-200;K-208;K-300;K-303;F-16;F-28;V-68;V-99 HA201/K-98/HAT605/HAT606/HAT607/HAT608/A-381/A-382/A-383/A-383/A-360/A-130/A-318/A-133/F-998/V-188/K-89/A-208B A1-D1, A1-D2, A2-DA, A2-D2, A2-D3, A3-G1T, A3-G2T, A6-G1T, A6-G2T, A6-G3T, A6-G F-139/F-136/V-163/F-137/B-13/V-168/F-138/X-168/V-185/V-183/V-188B/V-263PB/F-998B/E-103/B-18/B-19/K-80/K-82/K-86/K-188/K-88/X-136 A-90; G5; G6 A-209D Hearing Aid F-18/F-28/V-68/F-16/V-99/A-155/C-108/C-109/A-80/A-60/E-9/D-322/D-303/A-111/B-63/F-22/A-360/A-318/K-89/F-135B/A-208/V-168B/V-189B/A-130 Fetal Doppler, U8-25, U9-25 A2-D2/A6-G/A3-G1T/A6-G2/K-81/K-812/K-87 Hearing Aid with Wireless Technology

    Establishment Types

    Manufacture Medical Device