Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011061417

FEI Number

3011061417

Entity Name

IXENSOR CO LTD

City/State/Country

Taipei, TW

Establishment Address

11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,, Taipei 114, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

iXensor Co Ltd (Owner Number: 10048224)

Owner / Operator Contact Address

11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,, Taipei, TW-TPE 114, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192369

PMA Number

N/A

All Registered Proprietary Names

PixoTest PixoTest Vision Analysis System PixoTest Vision Analysis System PixoTest Vision Analysis System PixoTest

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	2017-11-13
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2024-05-22
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2014-12-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-04-02
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2024-05-22
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2019-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

Feng-Yu Lee Business: Dynamic Biotech Inc. Email: fengyulee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

iXensor Co Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017548799	iXensor USA Inc	San Juan Capistrano, CA, US

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
K790947	Macomb Chemical Co.	AUTO ENZYMATIC CHOLESTEROL	1979-06-28
K885023	Em Diagnostic Systems, Inc.	CHOLESTEROL TEST ITEM NUMBER: SR1011	1989-02-17
K771508	Instrumentation Laboratory CO	MULTISTAT III CHOLESTEROL TEST	1977-09-13

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-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Similar Registrations

Registration Number	Establishment Name	Location
3005706626	Bioptik Technology, Inc.	Jhunan Township Miaoli, TW
3004539335	CONDUCTIVE TECHNOLOGIES, INC.	York, PA, US
3014302067	MICROTECH MEDICAL (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011061417. Last updated year: 2026. Please use registration number 3011061417 when referencing this establishment in official correspondence.