Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026331889

FEI Number

3026331889

Entity Name

NINGBO HYSENT MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

NO.3 jinshui Road, Xiwu street, Fenghua District, Ningbo Zhejiang 315505, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Hysent Medical Technology Co., Ltd (Owner Number: 10087653)

Owner / Operator Contact Address

NO.3 jinshui Road, Xiwu street, Fenghua District, Ningbo, CN-ZJ 315505, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

surgical drape Ostomy bags spot acne patch; fixed stickers; sterile hydrocolloid dressing urine collection bags blister plaster Skin closure wart removal tool, mole removal tool sterile wound dressing Non-Adherent pad Medical tapes; transparent indwelling needle sticker; tattoo protective film; Sterile Skin Closure Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2023-03-24
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2023-03-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-03-24
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2023-03-24
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-03-24
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2023-03-24
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2023-03-24
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2023-03-24
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-03-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-03-24

Official Correspondent

yan wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Ningbo Hysent Medical Technology 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
3010034780	Smith & Nephew, Inc.	Lawrenceville, GA, US
3009420598	Primo Medical Group, Inc	W Bridgewater, MA, US
3041276890	SOLVENTUM US LLC (Apodaca)	Apodaca Nuevo Leon, MX
3013863160	HUBEI HENDRY MEDICAL APPLIANCE CO., LTD	Xiaogan City Hubei, CN
3009303243	JIANGSU CLASSIC NEW-TYPE MEDICAL PRODUCTS CO., LTD	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026331889. Last updated year: 2026. Please use registration number 3026331889 when referencing this establishment in official correspondence.