Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014368824

FEI Number

3014368824

Entity Name

ANJI HONGLI IMPORT & EXPORT CO.,LTD.

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

Room No. 2118. 21F. Yunhong Building. Anji County, Huzhou Zhejiang 313300, CN

Establishment Type(s)

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

Owner / Operator

ANJI HONGLI IMPORT & EXPORT CO.,LTD. (Owner Number: 10057349)

Owner / Operator Contact Address

Room No. 2118. 21F. Yunhong Building. Anji County, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cast Padding; Plaster Of Paris Bandages Medical Nonwoven Dressing Alcohol Pad; BZK Wipe Cast Paddings; Casting Tapes; Plaster Bandage; Stockinette Cotton Balls; Cotton Pads Medical Splints Stockinette Vaseline Gauze Abdominal Pads; Gauze Bandages; Gauze Compresses; Gauze Rolls; Gauze Sponges; Medical Gauze Skin Traction Kits Orthopedic Splints Elastic Adhesive Bandages; Kinesiology Tapes; Medical Tapes; Self-Adhesive Bandages; Sports

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2018-03-26
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2018-03-26
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2018-03-26
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2018-03-26
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-03-26
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2018-03-26
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2018-03-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-03-26
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-03-26
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2018-03-26
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2018-03-26
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-03-26

Official Correspondent

Yanfeng Wang

US Agent Details

James H Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

ANJI HONGLI IMPORT & EXPORT 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
9710020	ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.	HUZHOU Zhejiang, CN
3010309201	Fengtai County Guqiao Town Changxing Shoe Factory	Huainan City Anhui, CN
3007865243	ANJI FANG YUAN SANITARY MATERIAL CO., LTD.	ANJI Zhejiang, CN
3017264244	DJO, LLC	Carlsbad, CA, US
3008879776	J STERLING INDUSTRIES LLC	Kalamazoo, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014368824. Last updated year: 2026. Please use registration number 3014368824 when referencing this establishment in official correspondence.