Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042277637

FEI Number

3042277637

Entity Name

YANGZHOU SINJE BIOTECHNOLOGY CO.,LTD

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Unit 02-102, 02-202, Building 2, Yangzhou High end Equipment Intelligent Manufacturing Industrial, Zhongnan High tech Industrial Park, Yangzhou Development Zone, Jiulonghu Road, Shiqiao town, Yangzhou Jiangsu 225100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yangzhou Sinje Biotechnology Co.,Ltd (Owner Number: 10094373)

Owner / Operator Contact Address

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

pick; Toothbrush Sonic, Battery Powered Cleanser, Denture, over the counter Toothbrush, Manual Floss, Dental, dental flosser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-11-25
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2025-11-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-11-25
JES	Floss, Dental	Dental	Class 1	872.6390	2025-11-25

Official Correspondent

Jane Liu

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Yangzhou Sinje Biotechnology 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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042277637. Last updated year: 2026. Please use registration number 3042277637 when referencing this establishment in official correspondence.