Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042283853

FEI Number

3042283853

Entity Name

JINZHIDA MEDICAL (SHANGHAI) CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Block 1, No. 1388 North Jiasong Blvd, Shanghai 201806, CN

Establishment Type(s)

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

Owner / Operator

Jinzhida Medical (Shanghai) Co., Ltd (Owner Number: 10094467)

Owner / Operator Contact Address

Block 1, No. 1388 North Jiasong Blvd, Shanghai, CN-NOTA 201806, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BURN GEL, BURN BLANKET HYDROGEL SHEET DRESSING, AMORPHOUS HYDROGEL WOUND DRESSING, HYDROGEL IMPREGNATED DRESSING, BURN DRESSING, DRESSING PAD COMBINED ABSORBENT, DRY WIPES, GAUZE SPONGE, GAUZE SWABS 100% COTTON, CONFORMING BANDAGE, FLUFFY GAUZE BANDAGE ROLL, FLUFFY GAUZE SPONGE ABSORBENT GAUZE ROLL 100% COTTON, BURN PAD, COTTON BALL, DENTAL ROLL 100% COTTON, DRESSING PACK FOR HEAVY DRAINAGE, DISPOSABLE UNDERPAD, PROTECTIVE UNDERWEAR, BRIEFS, PULL-UPS, DIAPERS LUBRICANT PATIENT, STERILE LUBRICATING JELLY HYDROCONDUCTIVE DRESSING, CALCIUM ALGINATE DRESSING, GELLING FIBER DRESSING, SUPER ABSORBENT DRESSING, BORDERED GAUZE DRESSING, WATERPROOF COMPOSITE DRESSING, ACTIVATED CHARCOAL DRESSING CLOTH TAPE, SILK TAPE, PAPER TAPE, SILICONE TAPE NON-WOVEN RETENTION TAPE, REINFORCED IV TRANSPARENT DRESSINGS, SHOWER PROTECTOR, SKIN CLOSURE STRIPS, TRANSPARENT TAPE, FOLEY CATHETER HOLDER CLEANSING WIPES, WET WIPES ELASTIC BANDAGE, STRETCH BANDAGE ALCOHOL PREP PAD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-12-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-02
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2025-12-02
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-12-02
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-02
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-12-02
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-12-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-12-02
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-12-02

Official Correspondent

Ronggang Wang

US Agent Details

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

Related Public Records

Same Entity

Jinzhida Medical (Shanghai) 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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042283853. Last updated year: 2026. Please use registration number 3042283853 when referencing this establishment in official correspondence.