Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016696686

FEI Number

3016696686

Entity Name

JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Ji 'an Jiangxi, CN

Establishment Address

14th Industrial Building, Xiajiang Industrial Zone, Xiajiang, Ji 'an Jiangxi 331409, CN

Establishment Type(s)

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

Owner / Operator

Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. (Owner Number: 10086114)

Owner / Operator Contact Address

14th Industrial Building, Xiajiang Industrial Zone, Xiajiang, Ji 'an, CN-JX 331409, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Stone Retrieval Basket Disposable Endoscopy Valve Sets Bite Block Haemostasis clip Multi-chamber polyp Trap Disposable biopsy forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2024-06-06
JFE	Valve, Switching (Ploss)	Anesthesiology	Class 1	868.1965	2025-12-11
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2024-06-06
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-02-05
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-06-06
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2022-10-17

Official Correspondent

Yangfang Liu

US Agent Details

Qinlin Ding Email: device_medical@126.com Phone: (949) 3729018

Related Public Records

Same Entity

Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016696686. Last updated year: 2026. Please use registration number 3016696686 when referencing this establishment in official correspondence.