Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013863160

FEI Number

3013863160

Entity Name

HUBEI HENDRY MEDICAL APPLIANCE CO., LTD

City/State/Country

Xiaogan City Hubei, CN

Establishment Address

No.2 & No.4 Building, Yinhu Industry Park, South Xiaohan Avenue, Development District,, Xiaogan City Hubei 432000, CN

Establishment Type(s)

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

Owner / Operator

Hubei Hendry Medical Appliance Co., Ltd (Owner Number: 10084670)

Owner / Operator Contact Address

No.2 & No.4 Building, Yinhu Industry Park, South Xiaohan Avenue, Development District,, Xiaogan City, CN-HB 432000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Specimen Collection Swab Protecticve Barrier Ring Foam Heel; Silicone Wound Contact Layer; Island Dressing; Medical Adhesive I.V Dressing; I.V Fixing Dressing; Silicone Trilaminate Foam Border; Silicone Trilaminate Foam Non-Border; Super Absorbency Dressing; Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Hydrogel Wound Dressing; Foam Adhesive; Foam Non-Adhesive; Trilaminate Foam Adhesive; Trilaminate Foam Non-Adhesive Nonwoven Wound Dressing; NPWT Dressing; Silicone Foam Dressing; Silicone Secrum Dressing; Silicone Foam Lite Non-Border; Ostomy Bag Surgical Adhesive Dressing; Surgical Incise Adhesive Dressing; Surgical Incise Adhesive Film; Surgical Incise Dressing; Surgical Incise Film medical adhesive tape, pe tape Paper Tape; Zinc Oxide Adhesive Plaster; PU Film Tape; Nonwoven Fixing Tape Roll; Band Aid Tape Roll; Ostomy Abdomen Belt, Pocket Belt; Cannula Fixing Tape, Cannula Fixing Dressing, Catheter Fixing Dressing; Silk Tape; Ostomy Cream, Skin Barrier Strip, Ostomy Fastened Ring adhesive remover wipe, adhesive remover spray Urine bag Ostomy Pouch Deodorant Ostomy Skin Barrier Spray, Ostomy Powder, Ostomy Skin Protective Film, ostomy bag cover, waterproof protector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-12-12
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2022-12-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-11-22
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-03-20
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2024-11-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-12-12
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-12-12
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2024-10-27
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-12-12
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2025-09-15
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-12-12

Official Correspondent

Lei Chen

US Agent Details

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

Related Public Records

Same Entity

Hubei Hendry Medical Appliance 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013863160. Last updated year: 2026. Please use registration number 3013863160 when referencing this establishment in official correspondence.