Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006517436

FEI Number

3006517436

Entity Name

ZHEJIANG KANG LI DI MEDICAL ARTICLES CO., LTD.

City/State/Country

YUEQING CITY Zhejiang, CN

Establishment Address

DONGSHAN INDUSTRIAL ZONE, SHANG WU ZHAI LIUSHI TOWN, YUEQING CITY Zhejiang 325604, CN

Establishment Type(s)

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

Owner / Operator

ZHEJIANG KANG LI DI MEDICAL ARTICLES CO., LTD. (Owner Number: 9095719)

Owner / Operator Contact Address

DONGSHAN INDUSTRIAL ZONE, SHANG WU ZHAI LIUSHI TOWN, YUEQING CITY, CN-ZJ 325604, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ostomy Bag Disposable Colostomy Bags FIRST AID BLANKET SCISSORS Hydrogel dressing COOLING GEL SHEET Wound Dressing Transparent Wound Dressing Hydrocolloid Dressing Forceps, Tweezers Alginate Wound Dressing POLYURETHANE Foam Wound Dressing PU Foam Wound Dressing First Aid Kit , First Aid Bag, First Aid Box Self adhesive elastic bandag PBT Elastic Bandage MOUTH-TO-MOUTH MASK MOUTH-TO-MOUTH FILM MOUTH-TO-MOUTH DEVICE POVIDONE IODINE PREP PADS ALCOHOL PREP PAD IODINE COTTON BALL DRESSING PAD Adhesive bandage Adhesive tap FACE SHIELD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2009-12-08
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2006-12-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-12-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2006-12-18
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-12-18
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-12-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-04-08
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2021-02-25
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-12-18
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2007-04-20
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2006-12-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2006-12-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-12-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2006-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

ZHEJIANG KANG LI DI MEDICAL ARTICLES 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
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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

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
3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
3012002722	PRO-MED (WUXI)IMP.& EXP.CO.,LTD.	Wuxi Jiangsu, CN
3010198795	Shanghai Joy Crown Industry Co., Ltd	Pu Dong New Area Shanghai, CN
3014351477	STIEHL TECH	Lisle, IL, US
3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006517436. Last updated year: 2026. Please use registration number 3006517436 when referencing this establishment in official correspondence.