EPS BIO TECHNOLOGY CORP.

FDA Device Registration & Listing · Hsinchu, TW · Registration 3004130086

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004130086
FEI Number
3004130086
Entity Name
EPS BIO TECHNOLOGY CORP.
City/State/Country
Hsinchu, TW
Establishment Address
No. 8, R&D Rd. III, Hsinchu Science Park,, Hsinchu 30076, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EPS BIO TECHNOLOGY CORP. (Owner Number: 9058147)
Owner / Operator Contact Address
No. 8, R&D Road III, Hsinchu Science Park, TW-HSQ 30076, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133647
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-09-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-09-27
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-09-27
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-10-30
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-10-30
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2008-10-20
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-10-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2008-10-20
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2024-03-29
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-03-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-01-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-01-23
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-01-23
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-03-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-03-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-02-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-02-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-02-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-11-16
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-11-16
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2015-11-16

Official Correspondent

Silvia Lai

US Agent Details

Steve Kim Business: Oak Tree International Holdings Inc. Email: steve@oaktree-health.com Phone: (702) 4627295

Related Public Records

Same Entity

EPS BIO TECHNOLOGY CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004130086. Last updated year: 2026. Please use registration number 3004130086 when referencing this establishment in official correspondence.
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