Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005621808

FEI Number

3005621808

Entity Name

ANJI HONGDE MEDICAL PRODUCTS CO., LTD.

City/State/Country

HUZHOU Zhejiang, CN

Establishment Address

Building No.1,3,4,5,Bamboo Industrial Zone,Xiaofeng Town, Anji County, HUZHOU Zhejiang 313301, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANJI HONGDE MEDICAL PRODUCTS CO., LTD. (Owner Number: 9083742)

Owner / Operator Contact Address

Building No.1,3,4,5,Bamboo Industrial, Zone,Xiaofeng Town,Anji County, Huzhou, CN-ZJ 313301, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Cotton rolls Zigzag Cotton Cotton Rolls Antimicrobial Silver Carbon Dressing Disposable Sterile Scraper Disposable Sterile Cervical Sampler; Disposable Sterile Sampling Brush, Disposable Sampling Swab COTTON BUD;COTTON SWAB UMBILICAL cord CLAMP Ostomy Bags Vaseline Gauze Oil Emulsion dressing; Petrolatum dressing; Silicone Foam Dressing; Transparent dressing foam dressing; Heel foam dressing; hydrocolloid dressing; hydrocolloid foam dressing; nonwoven wound dressing silicone dressing; silicone foam dressing; super absorbency dressing;Chest Seal; Honey Gauze Dressing PE Apron, CPE Apron, PVC Apron, Non-woven Apron BZK wipe alcohol pad COVER, SHOE, OPERATING-ROOM isolation gown; lab coat ISLAND DRESSING Alginate Dressing Nurse Cap, Doctor Cap, Surgical Cap,bouffant cap,clip cap Sports Tapes Elastic Adhesive Bandages Medical Tapes Kinesiology Tapes Self-adhesive bandages ADHESIVE TAPE; ROLLER BANDAGE; STERILE ADHESIVE BANDAGE; TRIANGULAR BANDAGE; SILICONE TAPE Slides,cover microscope cover Plaster Bandage Cast Paddings Stockinette Casting Tapes Cotton tips, cotton swabs DISPOSABLE FACE MASK DISPOSABLE MEDICAL FACE MASK suction catheter,TRACHEOBRONCHIAL Tube nebulizer mask, simple oxygen mask Gauze Rolls Medical Gauze Gauze Bandages Gauze Sponges Gauze Compresses Abdominal Pads Gauze swabs,Gauze balls,fluff-dried gauze bandage,Gauze Zig-zag, Gauze Cutting, Lap sponges suction catheter,TRACHEOBRONCHIAL Tube Cast Padding Plaster of Paris Bandages Medical Nonwoven Dressing Disposable Nitrile Glove Xeroform Petrolatum Dressing anesthesia mask PIPETTE, PASTEUR FIRST AID KIT WITH DRUG Stocking, Medical Support Skin Traction Kits air splint BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE Elastic bandages emergency bandage Multiple ice bandage Military bandage Medical splints ROLL SPLINT First Aid Kit; Tourniquet Orthopedic splints

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-01-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-05
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-12-19
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2023-12-03
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2023-12-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-01-16
IWO	Apron, Protective	Radiology	Class 1	892.6500	2023-12-03
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-03-01
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2023-12-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-12-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-12-03
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-12-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-01-16
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2023-12-03
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2006-03-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-12-03
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-12-03
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-12-03
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2017-01-16
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-12-05
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2006-03-03
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2017-01-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2023-12-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-05
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2023-12-03
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2023-12-03
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2023-12-03
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2023-12-05
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2017-01-16
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2023-12-03
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2023-12-03
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-03-03
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2017-01-16
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2023-12-03
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2017-01-16

Official Correspondent

Zhang Yue Gen

US Agent Details

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

Related Public Records

Same Entity

ANJI HONGDE MEDICAL PRODUCTS 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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.

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3016826509	TAIZHOU RICH MEDICAL PRODUCTS CO., LTD.	TAIZHOU Jiangsu, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005621808. Last updated year: 2026. Please use registration number 3005621808 when referencing this establishment in official correspondence.