APEX BIOTECHNOLOGY CORP.

FDA Device Registration & Listing · HSINCHU, TW · Registration 9616936

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
9616936
FEI Number
3002671736
Entity Name
APEX BIOTECHNOLOGY CORP.
City/State/Country
HSINCHU, TW
Establishment Address
NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK, HSINCHU 30078, TW
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
APEX BIOTECHNOLOGY CORP. (Owner Number: 9034629)
Owner / Operator Contact Address
NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK, HSINCHU, TW-NOTA 30078, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Embrace EVO Embrace No Code BGMS Embrace TALK AutoSure Voice BGMS CVS Health Embrace Talking EvenCare G2 with Bluetooth AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM EvenCare G2 THE EDGE KetoBM Blood Glucose and Ketone Monitoring System Pip blood glucose monitoring system V1 Embrace WAVE Blood Glucose Monitoring System Embrace WAVE+ Blood Glucose Monitoring System BioTel Care THE EDGE KETONECOACH Pip glucose control solution V1 Embrace WAVE glucose control solution Microlife SmartBG glucose control solution UASure II uric acid control solution KetoBM Glucose control solution KetoBM Ketone control solution Embrace TALK glucose control solution GLUCOCARD W Test Strips Assure Titanium Test Strips

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 2012-10-23
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-10-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-04-16
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-04-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-04-16
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-10-31
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-11-18
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-11-18
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2007-06-12
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2021-12-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-12-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-03-30
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-01-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-03-14
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2013-03-14
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-03-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-03-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-06-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-04-08
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Clinical Chemistry Class 2 862.1345 2025-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

Yosuke Yamamoto Business: Arkray Factory USA, Inc Email: yamamotoy@arkrayusa.com Phone: (612) 9461481

Related Public Records

Same Entity

APEX BIOTECHNOLOGY 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
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

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-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616936. Last updated year: 2026. Please use registration number 9616936 when referencing this establishment in official correspondence.
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