BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    eBchek

    Reg #: 3005644014 · FEI: 3005644014 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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

    Regulatory Submissions

    510(k) Number
    K122181

    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
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    eBchek

    Establishment Types

    Manufacture Medical Device