Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014615175

FEI Number

3014615175

Entity Name

K-MED CO., LTD.

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

F5, No 18 West Wenchang Road, Yangzhou Jiangsu 225009, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

K-Med Co., Ltd. (Owner Number: 10081750)

Owner / Operator Contact Address

F5, No 18 West Wenchang Road, Yangzhou, CN-JS 225009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE BANDAGE, CAST Enema kit CONTAINER, SPECIMEN, URINE, DRUGS OF ABUSE, OVER THE COUNTER Adhensive tape and bandage, Medical tapes BEDPAN BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE FORCEPS, DRESSING, DENTAL MASK, OXYGEN SUCTION LINER CANNULA, INJECTION CANNULA, NASAL, OXYGEN BASIN, EMESIS Pouch, colostomy Medical Tube Holder Appliance, colostomy, disposable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-12-19
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2023-01-02
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2021-05-12
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2022-12-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-01-02
FOB	Bedpan	General Hospital	Class 1	880.6730	2022-12-19
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2021-05-12
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2023-01-02
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2021-05-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-12-17
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2021-05-12
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-05-12
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2022-12-19
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2022-12-19
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2024-12-17
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2022-12-19

Official Correspondent

Karl Zhang

US Agent Details

Charles Shen Business: Manton Business And Technology Services Email: Cyshen@Aol.Com Phone: (608) 2179358

Related Public Records

Same Entity

K-Med 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
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-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650

Similar Registrations

Registration Number	Establishment Name	Location
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3016577639	ACOSTA MEDICAL GROUP INC.	Houston, TX, US
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3013187142	ENDURE INDUSTRIES, INC.	Homer, NY, US
3010699203	Posey, S. de R.L. de C.V.	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014615175. Last updated year: 2026. Please use registration number 3014615175 when referencing this establishment in official correspondence.