Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003807757

FEI Number

3003807757

Entity Name

CHANGZHOU HUALIAN HEALTH DRESSING CO.,LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.55 Yuejin Road, Zouqu Town, Changzhou Jiangsu 213144, CN

Establishment Type(s)

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

Owner / Operator

Changzhou Hualian Health Dressing Co.,Ltd. (Owner Number: 10029342)

Owner / Operator Contact Address

No.55 Yuejin Road, Zouqu Town, Changzhou, CN-JS 213144, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile Rolled Cotton Gauze Alcohol Pad Gauze Roll skin protectant liquid bandage Strip, Temperature, Forehead, Liquid Crystal Face Mask Flat Tip tweezers Cotton swab First Aid Finger Splint Rubber Finger Protector Cotton nose bleed plugs First aid kit First Aid Only KINESOLOGY TAPE Elastic wrap ACE/Elastic wrap Scissors First Aid Only First Aid Kit Cooling Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2009-10-15
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2017-03-06
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2019-03-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-24
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-12-18
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2025-12-18
LZB	Finger Cot	General Hospital	Class 1	880.6250	2015-06-12
EFN	Cotton, Roll	Dental	Class 1	872.6050	2025-12-18
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2009-10-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-02-17
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2025-12-18
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2013-09-26
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-12-18

Official Correspondent

Rita Zhu

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

Changzhou Hualian Health Dressing 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Similar Registrations

Registration Number	Establishment Name	Location
3013391391	HERKIMER COUNTY CHAPTER NYSARC, INC.	Herkimer, NY, US
3012677665	TECHNO PLASTICS INDUSTRIES, INC.	Anasco, PR, US
3038131023	UNITED TECHNOLOGY VIETNAM COMPANY LIMITED	Quang Ha Commune Quang Ninh, VN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3043106338	SHENZHEN SPONGE NEW MATERIAL CO. LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003807757. Last updated year: 2026. Please use registration number 3003807757 when referencing this establishment in official correspondence.