Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021023673

FEI Number

3021023673

Entity Name

JIANGSU JIYUAN MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Taizhou Jiangsu, CN

Establishment Address

No. 48 CECEP(Taizhou) Environmental Protection Technology Industry Park,No.59 Meilan Road,Hailing District, Taizhou Jiangsu 225300, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Jiangsu Jiyuan Medical Technology Co., Ltd. (Owner Number: 10083005)

Owner / Operator Contact Address

No. 48 CECEP(Taizhou) Environmental Protection Technology Industry Park,No.59 Meilan Road, Hailing District,Taizhou,Jiangsu,China, Taizhou, CN-JS 225300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210270

PMA Number

N/A

All Registered Proprietary Names

Disposable Endoscopic Scissors Medical Endoscope Image Processing System WiScope® Single-Use Digital Hysteroscope, Model: OTU-HJ01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2023-01-17
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2021-10-20

Official Correspondent

Yunfeng Zong

US Agent Details

James Wang Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Jiangsu Jiyuan Medical Technology 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
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Similar Registrations

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3029929134	MACROLUX MEDICAL TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021023673. Last updated year: 2026. Please use registration number 3021023673 when referencing this establishment in official correspondence.