BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    iHealth Early Pregnancy Test (model: IHC-3000)

    Reg #: 3028107593 · FEI: 3028107593 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HIAN (HONG KONG) CO., LIMITED
    Registration Number
    3028107593
    FEI Number
    3028107593
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong.
    City
    Hong Kong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K241394

    Owner / Operator

    Firm Name
    Hian (Hong Kong) Co., Limited
    Operator Number
    10088625
    Address
    Unit 1002, 10th Floor, Perfect Commercial Building, 20 Austin Avenue, Tsim Sha Tsui, Kowloon, Hong Kong.
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    94085
    Country
    HK
    Correspondent
    Patric Wilson

    US Agent

    Business Name
    IHEALTH LABS, INC
    Contact Name
    Yange Wang
    Address
    880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US
    Email
    [email protected]
    Phone
    408 6638349

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    iHealth Early Pregnancy Test (model: IHC-3000)

    Establishment Types

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