TIANJIN EMPECS MEDICAL DEVICE CO., LTD.

Registration Details

Registration Name: TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Registration Number: 9616530
FEI Number: 3003116995
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: NO. 35 and 37, YINGCHENG STREET, HANGU, BINHAI NEW AREA
City: TIANJIN
Country: CN

Regulatory Submissions

510(k) Number: K162564

Owner / Operator

Firm Name: TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Operator Number: 9047576
Address: No. 35 and 37, Yingcheng Street, Hangu Binhai New Area
City: Tianjin
State: CN-NOTA
Postal Code: 300480
Country: CN
Correspondent: YOUNG DO Kim

US Agent

Business Name: LK Consulting Group USA, Inc.
Contact Name: Priscilla Chung
Address: 2552 Walnut Ave Ste 230
City: Tustin
State: CA
ZIP: 92780
Country: US
Email: [email protected]
Phone: 714 2025789

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Glucose Dehydrogenase, Glucose	LFR	Class 2	Clinical Chemistry	No	2017-06-15
System, Test, Blood Glucose, Over The Counter	NBW	Class 2	Clinical Chemistry	No	2017-06-15
Needle, Acupuncture, Single Use	MQX	Class 2	General Hospital	No	2016-01-20
Multiple Use Blood Lancet For Single Patient Use Only	QRL	Class 2	General, Plastic Surgery	No	2025-09-23
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	Class 2	General, Plastic Surgery	No	2025-09-23
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2014-07-28
Calculator/Data Processing Module, For Clinical Use	JQP	Class 1	Clinical Chemistry	No	2014-07-28
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2014-07-28

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 MAC ULTRA SMOOTH LANCET MAC ACUPUNCTURE NEEDLE HAENG LIM SEO WON ACUPUNCTURE NEEDL

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device