Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016863723

FEI Number

3016863723

Entity Name

Changsha Sinocare Inc.

City/State/Country

Changsha Hunan, CN

Establishment Address

No.265 Guyuan Road, Hi-Tech Zone, Changsha Hunan 410205, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changsha Sinocare Inc. (Owner Number: 10064101)

Owner / Operator Contact Address

No.265 Guyuan Road, Hi-Tech Zone,, Changsha, CN-HN 410205, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231476

PMA Number

N/A

All Registered Proprietary Names

TRUENESS Gold AQ Blood Glucose Monitoring System TRUENESS TRUENESS AIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-01-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-12-11
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-12-20

Official Correspondent

YAN ZIYING

US Agent Details

Jiangfeng Fei Email: fei@sinocare.com Phone: (908) 6663297

Related Public Records

Same Entity

Changsha Sinocare Inc.

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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
3007652384	MICROBIX	Mississauga Ontario, CA
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
3008514395	Telcare, LLC	Linwood, PA, US
3012118659	ASCENSIA DIABETES CARE HOLDINGS AG	Basel Basel-Stadt, CH
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016863723. Last updated year: 2026. Please use registration number 3016863723 when referencing this establishment in official correspondence.