BEUDAMED
    FDA Registration Active 🇨🇳 China

    HCG Home Use Pregnancy Test Strip (Colloidal Gold)

    Reg #: 3016447251 · FEI: 3016447251 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3016447251
    FEI Number
    3016447251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 777 Jimingshan Road, High-Tech Development Zone, 230088 Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA
    City
    Hefei Anhui
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240242

    Owner / Operator

    Firm Name
    ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
    Operator Number
    10062344
    Address
    No. 777 Jimingshan Road, High-Tech Development Zone, 230088 Hefei,Anhui, PEOPLES REPUBLIC OF CHINA
    City
    Hefei
    State
    Anhui
    Postal Code
    230088
    Country
    CN
    Correspondent
    Fengling Chen

    US Agent

    Business Name
    Medlinkt Business Technology Inc
    Contact Name
    Gloria Wang
    Address
    30 N Gould St Ste N Sheridan
    City
    Sheridan
    State
    WY
    ZIP
    82801
    Country
    US
    Email
    [email protected]
    Phone
    307 7769129

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    HCG Home Use Pregnancy Test Strip (Colloidal Gold) HCG Home Use Pregnancy Test Midstream (Colloidal Gold) HCG Home Use Pregnancy Test Cassette (Colloidal Gold)

    Establishment Types

    Manufacture Medical Device