Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038296436

FEI Number

3038296436

Entity Name

ETERNAL (SHANGHAI) MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Building 1, 9 Huiye Road, Chedun Town, Songjiang District, Shanghai 201611, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Eternal (Shanghai) Medical Technology Co., Ltd. (Owner Number: 10093239)

Owner / Operator Contact Address

Building 1, 9 Huiye Road, Chedun Town, Songjiang District, Shanghai, CN-NOTA 201611, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Urological Sampler Sets (IVX-NB-150) Ureteral Access Sheaths (IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250) Single Use Grasping Forceps (IVX-GF1-1806A, IVX-GF1-1808A, IVX-GF1-1810A, IVX-GF1-1812A) Flexible Video-Choledo-Cysto-Ureteroscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-04-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-05-07
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2025-04-17
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2025-04-17
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-04-17
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-04-17

Official Correspondent

Qing Sun

US Agent Details

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

Related Public Records

Same Entity

Eternal (Shanghai) 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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Similar Registrations

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3010300504	SERRES OY	Kauhajoki as Pirkanmaa, FI
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3019794450	KIEN AN TRANSPOWER COMPANY LIMITED	HO CHI MINH CITY Tay Ninh, VN
3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038296436. Last updated year: 2026. Please use registration number 3038296436 when referencing this establishment in official correspondence.