Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014302067

FEI Number

3014302067

Entity Name

MICROTECH MEDICAL (HANGZHOU) CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.108 Liuze St., Yuhang District, Hangzhou Zhejiang 311121, CN

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MicroTech Medical (Hangzhou) Co., Ltd. (Owner Number: 10074553)

Owner / Operator Contact Address

No.108 Liuze St., Cangqian, Yuhang District, Hangzhou, CN-ZJ 311121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193340

PMA Number

N/A

All Registered Proprietary Names

Gochek2 Blood Glucose Monitoring System; Gochek2 Connect Blood Glucose Monitoring System; Pancares App

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	2020-11-18

Official Correspondent

Dore Mark

US Agent Details

Dore Mark Business: Microtech Medical, inc. Email: dore.mark@microtechmd.com Phone: (408) 5440744

Related Public Records

Same Entity

MicroTech Medical (Hangzhou) Co., Ltd.

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

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

Registration Number	Establishment Name	Location
3005706626	Bioptik Technology, Inc.	Jhunan Township Miaoli, TW
3004539335	CONDUCTIVE TECHNOLOGIES, INC.	York, PA, US
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014302067. Last updated year: 2026. Please use registration number 3014302067 when referencing this establishment in official correspondence.