BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    OK BIOTECH CO., LTD.

    Reg #: 3005862821 · FEI: 3005862821 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    OK BIOTECH CO., LTD.
    Registration Number
    3005862821
    FEI Number
    3005862821
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO. 91, SEC. 2, Gongdao 5th Rd.
    City
    HSINCHU CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K162430

    Owner / Operator

    Firm Name
    OK BIOTECH CO., LTD.
    Operator Number
    9090860
    Address
    No. 91, Sec. 2, Gongdao 5th Rd.
    City
    Hsinchu City
    State
    TW-HSQ
    Postal Code
    30070
    Country
    TW

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Calculator/Data Processing Module, For Clinical Use JQP
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Syringe, Piston FMF
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Nebulizer (Direct Patient Interface) CAF
    Glucose Dehydrogenase, Glucose LFR
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ

    Proprietary Names

    TruePoint Equate Walgreens Prodigy OKB OTC hearing aid GV-SA3.60 Prodigy Count-a-Dose Densu Check Prodigy Control Solution Prodigy retail Control Solution Unistrip Control Solution Unistrip OKmeter Direct Perfect 3 Multi Smartest Glucowise Multi Smartest Glucowise Prodigy Mini Mist DocSpray Portable Nebulizer SMARTEST PERSONA Prodigy iConnect SOLO V2 Easy Talk Easy Plus II Multi Easy Plus II Smartest Persona II Smartest Persona II Multi SmartTest OK METER Prodigy No Coding Densu Check Pocket Densu Check No Coding Prodigy Pocket Prodigy AutoCode Prodigy Voice UniStrip 1 Prodigy Astro Prodigy Astro Pro Prodigy Preferred WowGoHealth SuperCheck Plus Multi SuperCheck Plus Prodigy Choice Prodigy Adjustable Depth Lancing Device OKmeter Match Perfect 3 Oracle Supercheck 1 SMARTEST PRONTO Prodigy AutoCode Eject Vapor Expert, Model: PY001/ PY002 / AZMALER-2 Mini Vapor, Model: PY-006

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device