BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    STANDARD GlucoNavii

    Reg #: 3012133212 · FEI: 3012133212 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SD BIOSENSOR, INC.
    Registration Number
    3012133212
    FEI Number
    3012133212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu
    City
    Suwon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K100398

    Owner / Operator

    Firm Name
    SD Biosensor, Inc.
    Operator Number
    10035779
    Address
    C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu
    City
    Suwon-si
    State
    Gyeonggi
    Postal Code
    16690
    Country
    KR
    Correspondent
    Hyo-Keun Lee

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    STANDARD GlucoNavii SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM SD CodeFree Catalogue Number 01GC11 Series

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility