BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EPS BIO TECHNOLOGY CORP.

    Reg #: 3004130086 · FEI: 3004130086 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    EPS BIO TECHNOLOGY CORP.
    Registration Number
    3004130086
    FEI Number
    3004130086
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 8, R&D Rd. III, Hsinchu Science Park,
    City
    Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K112272

    Owner / Operator

    Firm Name
    EPS BIO TECHNOLOGY CORP.
    Operator Number
    9058147
    Address
    No. 8, R&D Road III
    City
    Hsinchu Science Park
    State
    TW-HSQ
    Postal Code
    30076
    Country
    TW
    Correspondent
    Silvia Lai

    US Agent

    Business Name
    Oak Tree International Holdings Inc.
    Contact Name
    Steve Kim
    Address
    9550 S Eastern Ave Ste 253
    City
    Las Vegas
    State
    NV
    ZIP
    89123
    Country
    US
    Email
    [email protected]
    Phone
    702 4627295

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    Glucose Oxidase, Glucose CGA
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    EasyMax 15 EASYMAX T1 Glucheck Self-Monitoring Blood Glucose System, Glucheck Blood Glucose Test Strip EasyMax Lancing device EasyMax NG EasyMax LTC Glucertain II EasyMax V BeSmart 2IN1 Self Monitoring Blood Glucose System BeSure Self Monitoring Blood Glucose System EMV3.1 Self Monitoring Blood Glucose System EMV3.1 Pro Blood glucose System Glucertain

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device