Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015461866

FEI Number

3015461866

Entity Name

TIANJIN JIEYAXIN MEDICAL PLASTIC EQUIPMENT CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

No.1-26,Eight Street Light Industry Electronic Park,Yixingbu,Beichen District, Tianjin 300402, CN

Establishment Type(s)

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

Owner / Operator

TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. (Owner Number: 10060501)

Owner / Operator Contact Address

No.1-26,Eight Street Light Industry Electronic Park,Yixingbu,Beichen District, Tianjin, CN-TJ 300402, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

saliva ejector Gutta Percha Points, Gutta Percha Obturator Absorbent Paper Points micro applicator Air/water syringe tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2019-05-19
EKM	Gutta-Percha	Dental	Class 1	872.3850	2021-12-14
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2021-12-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-05-19
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2022-04-29

Official Correspondent

Juan Liu

US Agent Details

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

Related Public Records

Same Entity

TianJin Jieyaxin Medical Plastic Equipment 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

Registration Number	Establishment Name	Location
3015259866	SWIK Medical Solutions	Farmington Hills, MI, US
2133714	INTER-MED, INC.	Racine, WI, US
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 3015461866. Last updated year: 2026. Please use registration number 3015461866 when referencing this establishment in official correspondence.