APEX BIOTECHNOLOGY CORP.

Reg #: 9616936 · FEI: 3002671736 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: APEX BIOTECHNOLOGY CORP.
Registration Number: 9616936
FEI Number: 3002671736
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
City: HSINCHU
Country: TW

Regulatory Submissions

510(k) Number: K113208

Owner / Operator

Firm Name: APEX BIOTECHNOLOGY CORP.
Operator Number: 9034629
Address: NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
City: HSINCHU
State: TW-NOTA
Postal Code: 30078
Country: TW

US Agent

Business Name: Arkray Factory USA, Inc
Contact Name: Yosuke Yamamoto
Address: 8260 NW 27th Street, Suite 403
City: Miami
State: FL
ZIP: 33122
Country: US
Email: [email protected]
Phone: 612 9461481

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Test, Blood Glucose, Over The Counter	NBW	Class 2	Clinical Chemistry	No	2012-10-23
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2012-10-23
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2009-04-16
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2007-06-12
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	Class 1	Clinical Chemistry	No	2021-12-27
Calculator/Data Processing Module, For Clinical Use	JQP	Class 1	Clinical Chemistry	No	2013-03-14
Prescription Use Blood Glucose Meter For Near-Patient Testing	PZI	Class 2	Clinical Chemistry	No	2025-08-21
Uric Acid Test System For At Home Prescription Use	PTC	Class 1	Clinical Chemistry	No	2025-04-13
Glucose Dehydrogenase, Glucose	LFR	Class 2	Clinical Chemistry	No	2017-05-25

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 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 GlucoCard Expression UASure II Blood Uric Acid Monitoring System ReliOn Prime Test Strips GLUCOCARD Vital Test Strips Assure Platinum Test Strips EvenCare G3 Harmony microdot PRO

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)