Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005706626

FEI Number

3005706626

Entity Name

Bioptik Technology, Inc.

City/State/Country

Jhunan Township Miaoli, TW

Establishment Address

No.188, Jhonghua South Road, Gongguan Village, Jhunan Township Miaoli 35057, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bioptik Technology, Inc. (Owner Number: 10023609)

Owner / Operator Contact Address

No. 188, Jhonghua South road,, Gongguan Village,, Jhunan Township, TW-MIA 35057, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053312

PMA Number

N/A

All Registered Proprietary Names

EasyMate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2007-12-05

Official Correspondent

Chin-Chang Yang

US Agent Details

Jennifer Reich Business: Harvest & Victory Consulting Corp.(USA) Email: ftcr67@gmail.com Phone: (928) 8638140

Related Public Records

Same Entity

Bioptik Technology, Inc.

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
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
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

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

Similar Registrations

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3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
2016706	Bio-Rad Laboratories Inc.	IRVINE, CA, US
8032314	AXIS-SHIELD DIAGNOSTICS, LTD.	DUNDEE Scotland, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005706626. Last updated year: 2026. Please use registration number 3005706626 when referencing this establishment in official correspondence.