BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    CONTOUR NEXT ONE Blood Glucose Monitoring System

    Reg #: 3009204541 · FEI: 3009204541 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PT PHC INDONESIA
    Registration Number
    3009204541
    FEI Number
    3009204541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kawasan Industri MM2100 Blok O-1
    City
    Cikarang Barat Bekasi Jawa Barat
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K160682

    Owner / Operator

    Firm Name
    PT PHC Indonesia
    Operator Number
    10038465
    Address
    Kawasan industri MM2100 Blok O-1,
    City
    Cikarang Barat Bekasi
    State
    Jawa Barat
    Postal Code
    17520
    Country
    ID
    Correspondent
    Ili Zulkarnaen

    US Agent

    Business Name
    PHC Corporation of North America
    Contact Name
    Steven Hubbard
    Address
    1300 Michael Dr, Ste A
    City
    Wood Dale
    State
    IL
    ZIP
    60191
    Country
    US
    Email
    [email protected]
    Phone
    551 4829284

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    CONTOUR NEXT ONE Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)