Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003403221

FEI Number

3003403221

Entity Name

QIDONG FARJOY MEDICAL MATERIAL CO., LTD.

City/State/Country

Qidong Jiangsu, CN

Establishment Address

No.1858 Nanyuan West Rd. Economic Development Zone, Huilong Town, Qidong Jiangsu 226200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Qidong Farjoy Medical Material Co., Ltd. (Owner Number: 10051819)

Owner / Operator Contact Address

No.1858 Nanyuan West Rd. Economic Development Zone, Huilong Town, Qidong, CN-JS 226200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Absorbent Pad Skin Closure Strips Hydrocolloid Dressing/Plaster; Hydrogel Dressing; Infusion Plaster; Wound Dressing; Foam Dressing Medical Sterile PU Dressing Ostomy Bag Medical Tape Plaster; Skin Closure; Stops Bleeding Plaster; Tape And Bandage, Adhesive BANDAGE, ELASTIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2019-06-10
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2023-07-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-06-10
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2019-06-10
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-01-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-05-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-06-10

Official Correspondent

Yi Lu

US Agent Details

James Liao Email: usa@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Qidong Farjoy Medical Material 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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
3004651943	KURTSAN PHARMACEUTICALS, INC.	Bandirma Balikesir, TR
3012047128	ATHFAR 828, Inc.	Big Rapids, MI, US
3014666579	SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Zaozhuang Shandong, CN
3007663056	SHANGHAI HUIHU MEDICAL APPLIANCE CO. LTD.	Shanghai, CN
3015068387	GEORGE COUREY INC	Montreal Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003403221. Last updated year: 2026. Please use registration number 3003403221 when referencing this establishment in official correspondence.