Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015142802

FEI Number

3015142802

Entity Name

NANJING ANJIAN MEDICAL DEVICE CO.,LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

Building 9 No. 16 Xinggu Road Guli Street Jiangning District, Nanjing Jiangsu 211100, CN

Establishment Type(s)

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

Owner / Operator

Nanjing Anjian Medical Device Co.,Ltd. (Owner Number: 10059266)

Owner / Operator Contact Address

Building 9 No. 16 Xinggu Road Guli Street Jiangning District, Nanjing, CN-JS 211100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112110

PMA Number

N/A

All Registered Proprietary Names

Skin barrier film Hydrogel Gauze Conforming Stretch Gauze PVC Urethral Catheter Fibergel Dressing Gauze Sponges Foam Dressing Silicone Transparent Dressing Silicone Foam Dressing Hydrogel Dressing Bordered Gauze Alginate Dressing High Absorbent Pad Silicone Wound Contact Dressing Super Absorbent Dressing Antimicrobial Gauze Antimicrobial Gauze Wound Dressing Ostomy Pouch Ostomy Bag Silver Alginate Dressing Urinary Leg Bag Urine Bag Silver Silicone Foam Dressing Adhesive remover wipe Catheter Insertion Tray Sterile Syringe with Needle Ostomy Pouch Deodorant Ostomy Pouch Deodorant Silicone Foley Catheter Hydrophilic Catheter Intermittent Catheter Self Catheterization Kit Catheter Stabilization Device Silicone Tape Silver Foam Dressing Sterile Lubricate Jelly

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2018-12-16
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-10-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-10-21
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-10-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-12-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-21
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-10-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-21
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-10-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-21
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2018-12-16
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2024-10-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-05-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-05-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-13
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-10-16
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2024-10-21
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-10-21
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2024-10-21
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2024-10-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-10-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-21
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2024-10-21

Official Correspondent

Yehua Zhou

US Agent Details

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

Related Public Records

Same Entity

Nanjing Anjian Medical Device 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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
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-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015142802. Last updated year: 2026. Please use registration number 3015142802 when referencing this establishment in official correspondence.