BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VIVOSENS INC

    Reg #: 3018126397 · FEI: 3018126397 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    VIVOSENS INC
    Registration Number
    3018126397
    FEI Number
    3018126397
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    44 Tehama Street, Suite 409
    City
    San Francisco
    State
    CA
    ZIP
    94105
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212447

    Owner / Operator

    Firm Name
    Vivosens Inc
    Operator Number
    10085777
    Address
    44 Tehama Street, Suite 409
    City
    San Francisco
    State
    CA
    Postal Code
    94105
    Country
    US
    Correspondent
    Gozde Buyukacaroglu

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Tube, Sedimentation Rate GHC
    Refractometer For Clinical Use JRE
    Test, Erythrocyte Sedimentation Rate JPH
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Urine Leukocyte LJX
    Visual, Pregnancy Hcg, Prescription Use JHI
    Paper, Obstetric Ph LNW
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA

    Proprietary Names

    Vivoo Vivoo LH Ovulation Test Vivoo Sediva Sedimentation Test Tube Vivoo Sediva Sedimentation Test Vivoo hCG Pregnancy Test Vivoo FSH Fertility Test

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility