Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022346573

FEI Number

3022346573

Entity Name

Altek Medical (kunshan) limited

City/State/Country

Kunshan Free Trade Zone Jiangsu, CN

Establishment Address

2F, Building No.1, No. 77, 3rd Main Street, Kunshan Free Trade Zone Jiangsu 215301, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Altek Biotechnology Corporation (Owner Number: 10029462)

Owner / Operator Contact Address

4F, No. 12, Li-Hsin Road,, Science-Based Industrial Park, Hsinchu, TW-HSZ 300, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IWL2020 Blood Glucose Monitoring System Accu-Chek Instant Blood Glucose Monitoring System IWLCaretech Blood Glucose Monitoring System Pilot Program Participants Only

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	2022-05-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-10-27
FTT	Camera, Still, Surgical	General, Plastic Surgery	Class 1	878.4160	2009-05-17

Official Correspondent

No official correspondent registered.

US Agent Details

VIVIAN CHANG Email: vchang.aplus@gmail.com Phone: (626) 3755131

Related Public Records

Same Entity

Altek Biotechnology Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007703432	Altek Biotechnology Corporation	Hsinchu Hsinchu (City), TW
3030311186	Altek Medical Sdn. Bhd.	Iskandar Puteri Johor, MY

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

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

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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 3022346573. Last updated year: 2026. Please use registration number 3022346573 when referencing this establishment in official correspondence.