Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005246939

FEI Number

3005246939

Entity Name

JIANGXI SANXIN MEDTEC CO.,LTD.

City/State/Country

Nanchang Jiangxi, CN

Establishment Address

No.999 Fushan Road, Xiaolan Economic, Development, Nanchang Jiangxi 330200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Jiangxi Sanxin Medtec Co., Ltd. (Owner Number: 10027789)

Owner / Operator Contact Address

No.999 Fushan Road, Xiaolan Economic,, Development, Nanchang, CN-JX 330200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142797

PMA Number

N/A

All Registered Proprietary Names

SANSIN Tubing Sets for Hemodialysi YIXIN SAFETY SYRINGE YI XIN SAFETY SYRINGE YI XIN STERILE SYRINGE YIXIN STERILE SYRINGE FOR SINGLE USE FOR SINGLE USE Disposable Medical Face Masks I.V. Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2021-10-20
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2008-12-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-12-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-12-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-10-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-08-14

Official Correspondent

Ganying Wang

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Jiangxi Sanxin Medtec 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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
8030665	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
2011171	Sterigenics US LLC	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005246939. Last updated year: 2026. Please use registration number 3005246939 when referencing this establishment in official correspondence.