Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007360701

FEI Number

3007360701

Entity Name

MEDWELL MEDICAL PRODUCTS CO., LTD.

City/State/Country

Jiujiang City Jiangxi, CN

Establishment Address

No. 888 Fenglin Road, Fenglin Town, Dean County,, No .999 Xue Song Road, Fenglin Town, Dean County,, Jiujiang City Jiangxi 330400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medwell Medical Products Co., Ltd. (Owner Number: 10027483)

Owner / Operator Contact Address

Fenglin Town, Dean County,, Jiangxi Province, China, Dean County, CN-JX 330400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDWELL MEDICAL PRODUCTS CO.,LTD MEDWELL MEDICAL PRODUCTS CO.,LTD MEDWELL MEDICAL PRODUCTS CO.,LTD MEDWELL MEDICAL PRODUCTS CO.,LTD MEDWELL MEDICAL PRODUCTS CO.,LTD

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	2008-11-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-11-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-09-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-11-12
EFN	Cotton, Roll	Dental	Class 1	872.6050	2008-11-12

Official Correspondent

zhao jinming

US Agent Details

Dennis Xu Business: Performance International, Inc. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Medwell Medical Products 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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 3007360701. Last updated year: 2026. Please use registration number 3007360701 when referencing this establishment in official correspondence.