BEUDAMED
    FDA Registration Active 🇨🇳 China

    INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.

    Reg #: 3013332582 · FEI: 3013332582 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    5

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.
    Registration Number
    3013332582
    FEI Number
    3013332582
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.699 Juxin Street,High-tech Industrial Development Zone
    City
    Qian'an Hebei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K250398

    Owner / Operator

    Firm Name
    INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD.
    Operator Number
    10059626
    Address
    NO.699 JUXIN STREET,HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE
    City
    Qian'an
    State
    Hebei
    Postal Code
    064400
    Country
    CN
    Correspondent
    Yan Hua

    US Agent

    Business Name
    Neptune Technology INC
    Contact Name
    Fiona Wang
    Address
    19 Calle Arcos
    City
    Rsm
    State
    CA
    ZIP
    92688
    Country
    US
    Email
    [email protected]
    Phone
    949 8749889

    Products

    Device Name Product Code
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Reagent, Coronavirus Serological QKO
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    LH Ovulation Rapid Test Strip LH Ovulation Rapid Test Cassette LH Ovulation Rapid Test Midstream Innovita Flu A/B Antigen Rapid Test Innovita 2019-nCoV Ab Test (Colloidal Gold) easy@Home HCG Pregnancy Test Cassette, easy@Home HCG Pregnancy Test Midstream, easy@Home HCG Pregnancy Test Strip INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Midstream INNOVITA HCG Pregnancy Rapid Test Cassette Innovita HCG Pregnancy Rapid Combo Test

    Establishment Types

    Manufacture Medical Device