Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007392007

FEI Number

3007392007

Entity Name

JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD.

City/State/Country

Nanchang Jiangxi, CN

Establishment Address

No.39 Yunqiao South Road, Yunqiao street, Jinxian County, Nanchang Jiangxi 331700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangxi Hongda Medical Equipment Group LTD. (Owner Number: 10072239)

Owner / Operator Contact Address

No.39 Yunqiao South Road, Yunqiao street, Jinxian County, Nanchang, CN-JX 331700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163161

PMA Number

N/A

All Registered Proprietary Names

Medical PVC Examination Gloves Single-Use Medical Face Mask Sterile Single-use Infusion Set Single-use protective clothing Sterile Syringe with Safety Needle Sterile Single-use Syringe with Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-07-12
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-10-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-10-31
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-11-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-11-17

Official Correspondent

Xiaohua Yang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Jiangxi Hongda Medical Equipment Group 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3020106122	BINH AN MEDICAL CO., LTD	Dong Trieu Township, Quang Ninh, VN
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
3012304513	JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
3012317628	ZIBO LING YUN MEDICAL PRODUCTS CO., LTD.	Zibo Shandong, CN
3015477649	SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD	HEZE CITY Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007392007. Last updated year: 2026. Please use registration number 3007392007 when referencing this establishment in official correspondence.