BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    eBketone blood ketone monitoring system

    Reg #: 3005644014 · FEI: 3005644014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VISGENEER, INC.
    Registration Number
    3005644014
    FEI Number
    3005644014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 335, SEC. 6, Zhonghua ROAD
    City
    HSINCHU CITY Hsinchu (City)
    Country
    TW

    Owner / Operator

    Firm Name
    VISGENEER, INC.
    Operator Number
    9084502
    Address
    NO. 335, SEC. 6, Zhunghua ROAD
    City
    HSINCHU CITY
    State
    TW-NOTA
    Postal Code
    30094
    Country
    TW
    Correspondent
    Ken-Shwo - Dai

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN

    Proprietary Names

    eBketone blood ketone monitoring system eBketone blood ketone meter eBketone blood ketone test strip eBketolife blood ketone meter eBketolife blood ketone test strip eBketolife blood ketone monitoring system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device