TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

FDA Device Registration & Listing · TIANJIN, CN · Registration 9616530

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616530
FEI Number
3003116995
Entity Name
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
City/State/Country
TIANJIN, CN
Establishment Address
NO. 35 and 37, YINGCHENG STREET, HANGU, BINHAI NEW AREA, TIANJIN 300480, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. (Owner Number: 9047576)
Owner / Operator Contact Address
No. 35 and 37, Yingcheng Street, Hangu Binhai New Area, Tianjin, CN-NOTA 300480, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K111456
PMA Number
N/A

All Registered Proprietary Names

Medisign GH83 Blood Glucose Monitoring System Medisign GH83 BT Blood Glucose Monitoring System Medisign GH81 BT Blood Glucose Monitoring System Medisign GH82 BT Blood Glucose Monitoring System Medisign GH82 Blood Glucose Monitoring System Medisign GH81 Blood Glucose Monitoring System Prove GH82 Blood Glucose Monitoring System Prove GH82 Blood Glucose Test Strip Prove GH Glucose Control Solution H.L. SEO WON ACUPUNCTURE NEEDLES Allevy Lancet CX11B1 Smart Diabetes V Blood Glucose Monitoring System Smart Diabetes V Pro Blood Glucose Monitoring System Medisign MM3000 Multi Blood Glucose Monitoring System Medisign MM3000 Blood Glucose Monitoring System Medisign MM1000 BT, MM1100 BT, MM1200 BT Blood Glucose Monitoring System Smart Diabetes Bluetooth, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System Medisign MM1000 BT MULTI, MM1100 BT MULTI, MM1200 BT MULTI Blood Glucose Monitoring System CareTouch Lancing Device CareTouch Lancet Allevy Lancing Device Allevy MM1100 Blood Glucose Meter Clarity BG1000 Blood Glucose Monitoring System Smart Diabetes Blood Glucose Monitoring System Smart Diabetes Pro Blood Glucose Test Strip Clarity BG1000 Glucose Control Solution Smart Diabetes Blood Glucose Test Strip EVENCARE ProView Blood Glucose Monitoring System Clarity BG1000 Blood Glucose Test Strip EVENCARE ProView Glucose Control Solution Smart Diabetes Pro Blood Glucose Monitoring System EVENCARE ProView Blood Glucose Test Strip Smart Diabetes Glucose Control Solution CareTouch Glucose Control Solution CareTouch Blood Glucose Test Strip CareTouch Blood Glucose Monitoring System Medisign MM1000 Multi Blood Glucose Test Strip Medisign MM1000 Multi Blood Glucose Monitoring System Medisign Glucose Control Solutions Medisign MM1000 Blood Glucose Monitoring System Medisign MM1200 Blood Glucose Monitoring System Medisign MM1100 Multi Blood Glucose Test Strip Medisign MM1100 Blood Glucose Monitoring System Medisign MM1200 Blood Glucose Test Strip Medisign MM1000 Blood Glucose Test Strip Medisign MM1100 Blood Glucose Test Strip Medisign MM1200 Multi Blood Glucose Test Strip Medisign MM1100 Multi Blood Glucose Monitoring System Medisign MM1200 Multi Blood Glucose Monitoring System CareLiving MM1100 Blood Gucose Test Strip CareLiving MM1100 Blood Glucose Meter CareLiving Glucose Control Solution CareLiving MM1100 Blood Glucose Monitoring System Allevy Glucose Control Solution Allevy MM1100 Blood Glucose Test Strip Allevy MM1100 Blood Glucose Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2017-06-15
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-06-15
MQX Needle, Acupuncture, Single Use General Hospital Class 2 880.5580 2016-01-20
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2025-09-23
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-09-23
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-05-14
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2024-05-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-07-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-07-28
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2014-07-28
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-07-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-05-25
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2017-05-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-05-25
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2024-03-27
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-03-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-03-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-03-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-03-20

Official Correspondent

YOUNG DO Kim

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 2025789

Related Public Records

Same Entity

TIANJIN EMPECS MEDICAL DEVICE 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
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15
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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

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-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number Establishment Name Location
3014353121 VIDAN DIAGNOSTICS, LLC San Antonio, TX, US
3012118659 ASCENSIA DIABETES CARE HOLDINGS AG Basel Basel-Stadt, CH
1810909 Ascensia Diabetes Care US Inc. Valhalla, NY, US
2954323 ABBOTT DIABETES CARE INC. ALAMEDA, CA, US
3003741676 ANDON HEALTH CO., LTD TIANJIN, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616530. Last updated year: 2026. Please use registration number 9616530 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.