BEUDAMED
    FDA Registration Active 🇨🇳 China

    HORMONElife™ Early Result Pregnancy Test Strip

    Reg #: 3023322455 · FEI: 3023322455 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Registration Number
    3023322455
    FEI Number
    3023322455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 268, Shenzhou Road, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150022

    Owner / Operator

    Firm Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Operator Number
    9064561
    Address
    No.8 lizhishan Road, Science City, Huangpu District, 510663
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    Jihua - Wang

    US Agent

    Business Name
    LSI International Inc.
    Contact Name
    Joe Shia
    Address
    504 East Diamond Ave., Suite I
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

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

    Proprietary Names

    HORMONElife™ Early Result Pregnancy Test Strip Wondfo One Step HCG Urine Pregnancy Test Midstream VeriQuick® EARLY RESULT PREGNANCY TEST Modern Fertility Pregnancy Test Wondfo One Step HCG Urine Pregnancy Test Strip Best Choice Early Result PREGNANCY TEST Early Result Pregnancy Test Sevenground Trading B.V. iProven Pregnancy Test Wondfo® Early Result Pregnancy Test Strip Wondfo One Step HCG Urine Pregnancy Test Cassette Early Detection Pregnancy Test Modern Fertility Early Pregnancy Test Best Choice® One Step EARLY PREGNANCY TEST Bird&Be Early Results Pregnancy Test Wondfo® Early Result Pregnancy Test Early Results Pregnancy Tests Preview® HCG Early Result Pregnancy Test (Strip) INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP Pregnancy Test Mintegrity® HCG Early Result Pregnancy Test Best Choice One Step EARLY PREGNANCY TEST Best Choice® Early Result PREGNANCY TEST FAMILY WELLNESSTM EARLY RESULT PREGNANCY TEST Preview® HCG Early Result Pregnancy Test (Midstream) BABYlife™ Early Result Pregnancy Test Get Stix Inc. Early Pregnancy Test ALYK, Inc., LOLA Early Discovery Pregnancy Test Masena Invest B.V. iProven Pregnancy Test Early Pregnancy Test six Early Pregnancy Test Preview® HCG Early Result Pregnancy Test Wondfo® HCG Early Result Pregnancy Test (Midstream) Wondfo® Extra Sensitive Pregnancy Test Strip early pregnancy tests

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198