Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030017177

FEI Number

3030017177

Entity Name

YIWU KEBON HEALTHCARE CO., LTD.

City/State/Country

Yiwu Zhejiang, CN

Establishment Address

201 Yongmao Road, Choujiang Street, Yiwu Zhejiang 322000, CN

Establishment Type(s)

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

Owner / Operator

Yiwu Kebon Healthcare Co., Ltd. (Owner Number: 10089004)

Owner / Operator Contact Address

201 Yongmao Road, Choujiang Street, Yiwu, CN-ZJ 322000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dialator, Nasal Disinfectant, Medical Devices Radiographic Protective Glove Dressing, Wound, Occlusive Bandage, Elastic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2024-01-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2023-10-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-10-27
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-01-09
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-10-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-10-27
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2023-10-27
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2023-10-27
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-10-27
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-10-27
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2024-01-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-01-09
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-10-27
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-10-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-10-27
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2023-10-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-10-27
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-01-09
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Yiwu Kebon Healthcare 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3009227226	AIRMAX B.V.	Oegstgeest Zuid-Holland, NL
3011956575	G & G PRODUCTS, LLC	Kennebunk, ME, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3015456954	ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD.	Huzhou Zhejiang, CN
3016450032	PLANET HOLDINGS LIMITED	Hong Kong, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030017177. Last updated year: 2026. Please use registration number 3030017177 when referencing this establishment in official correspondence.