BEUDAMED
    FDA Registration Active 🇨🇳 China

    Dealmed HCG Pregnancy Test Strip

    Reg #: 3023322455 · FEI: 3023322455 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    47
    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
    K043443

    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

    Dealmed HCG Pregnancy Test Strip Saless Enterprises Inc. Pregnancy Test (strip) Greenbrier International Inc. Assured Pregnancy Test Wondfo USA Co., Ltd. Preview Pregnancy Test Strip The Babydust Method hCG Pregnancy Test Cassette Saless Enterprises Inc. New Choice Pregnancy Test (cassette) Independent Medical Co-op Inc., IMCO HCG Urine Pregnancy Test RefuAH One Step Urine hCG Pregnancy Test Cassette One Step HCG Urine Test dealmed HCG Pregnancy Test Cassette Easy At Home Medical LLC Easy@Home Early Pregnancy Test (midstream) SMC Direct Inc. RefuAH One Step HCG Urine Test (cassette) Heritage House '76 Inc. Quick & Clear hCG Urine Pregancy Tests (Cassette) Saless Enterprises Inc. U-Check Pregnancy Test (strip) The Babydust Method hCG Pregnancy Test Midstream Wondfo® Pregnancy Test Strip Saless Enterprises Inc. U-Check Pregnancy Test (cassette) One Step HCG Urine Pregnancy Test Cassette THE BABYDUST METHOD HCG Pregnancy Test Wondfo One Step HCG Urine Pregnancy Test The Babydust Method hCG Pregnancy Test Strip Easy At Home Medical LLC Easy@Home Early Pregnancy Test (cassette) MEDLINE hCG PREGNANCY TEST STRIP (URINE) 25mIU/mL Pregnancy Test Strip Pregnancy Test Midstream RefuAH One Step Urine hCG Pregnancy Test Strip pregmate® Pregnancy Tests CLARITY MIDSTREAM PREGNANCY TEST INDICAID™ HCG PREGNANCY TEST STRIP Shenzhen Aukeyhi Technology Co., Ltd., AFAC Pregnancy Test Easy At Home Medical LLC Easy@Home Early Pregnancy Test (strip) One Step HCG Urine Pregnancy Test Wondfo USA Co., Ltd., Preview Fertility Combination Tests {Preview Pregnancy Test Strip} SMC Direct Inc. RefuAH One Step HCG Urine Test (strip) SCI International Inc. New Choice Pregnancy Test (cassette) Clarity® MIDSTREAM PREGNANCY TEST Wondfo® Fertility Combination Tests (Wondfo® Pregnancy Test Strip) Medline hCG Pregnancy Test Strip (Urine) Saless Eterprises Inc. Baby Test Pregnancy Test (cassette) MEDLINE hCG PREGNANCY TEST CASSETTE (URINE) 25mIU/mL Clarity Midstream Pregnancy Test, OTC-HCGMID2 PREGNANCY TEST Pregnancy Test Mini-Midstream UA One Step HCG Urine Test MEDLINE hCG Pregnancy Test Cassette (Urine) PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE PREGNANCY TEST) HORMONElife™ Pregnancy Test Strip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198