Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044858680

FEI Number

3044858680

Entity Name

JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Building 4, No. 239 Cheyang Road, Chedun Town Songjiang District, Shanghai 201600, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Jieno Youcheng Medical Technology (Shanghai) Co., LTD. (Owner Number: 10095335)

Owner / Operator Contact Address

Building 4, No. 239 Cheyang Road, Chedun Town Songjiang District, Shanghai, CN-NOTA 201600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hoover Negative Pressure Access Sheath KMC Kyphoplasty System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-02-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-02-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2026-02-27

Official Correspondent

Mei Du

US Agent Details

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

Related Public Records

Same Entity

Jieno Youcheng Medical Technology (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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3030511423	ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3035480112	SEPLOU (ZHUHAI) CO.,LTD.	Zhuhai Guangdong, CN
3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA
3032959393	CALYXO, INC.	Pleasanton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044858680. Last updated year: 2026. Please use registration number 3044858680 when referencing this establishment in official correspondence.