Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007774461

FEI Number

3007774461

Entity Name

Changzhou Shengjie Medical Product Co., Ltd

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No. 216, Liangchang Road, Changzhou Jiangsu 213200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Changzhou Shengjie Medical Product Co., Ltd (Owner Number: 10029972)

Owner / Operator Contact Address

No. 216, Liangchang Road, Changzhou, CN-JS 213200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Saliva tips ,Evacuator tips, Surgical tips Tray Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-09-06
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2023-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Changzhou Shengjie Medical Product 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

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1123010	TRINITY STERILE, INC.	SALISBURY, MD, US
3016789258	EG-MEDACYS DEVICES(SHENZHEN)CO.,LTD	SHENZHEN Guangdong, CN
3014146451	HUBEI V-MEDICAL PRODUCTS CO., LTD.	Xiantao Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007774461. Last updated year: 2026. Please use registration number 3007774461 when referencing this establishment in official correspondence.