BEUDAMED
    FDA Registration Active 🇨🇳 China

    On Call Vivid Blood Glucose Monitoring System

    Reg #: 9615507 · FEI: 3002829675 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ACON BIOTECH (HANGZHOU) CO., LTD.
    Registration Number
    9615507
    FEI Number
    3002829675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 210 Zhenzhong Road, West Lake District
    City
    HANGZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112653

    Owner / Operator

    Firm Name
    ACON Laboratories Inc.
    Operator Number
    9033096
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Catherine Shi

    US Agent

    Business Name
    ACON LABORATORIES INC.
    Contact Name
    Catherine Shi
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 8758068

    Products

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

    Proprietary Names

    On Call Vivid Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)