Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037050339

FEI Number

3037050339

Entity Name

TIANJIN ETHYLENE OXIDE STERILIZATION TECHNOLOGY CO.,LTD.

City/State/Country

Tianjin, CN

Establishment Address

6th Building 120 Xinxing Road, West Zone, TEDA, Tianjin 300462, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Tianjin Ethylene Oxide Sterilization Technology Co.,Ltd. (Owner Number: 10092902)

Owner / Operator Contact Address

6th Building 120 Xinxing Road, West Zone, TEDA, Tianjin, CN-TJ 300462, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2025-03-05
DRC	Trocar	Cardiovascular	Class 2	870.1390	2025-03-05
NKQ	Guidewire, Catheter, Reprocessed	Cardiovascular	Class 2	870.1330	2025-03-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-03-05

Official Correspondent

Qinghai Zhao

US Agent Details

Shan Wan Business: Genesis Medtech(USA) Inc. Email: Shan.Wan@Gmedtech.com Phone: (612) 8676673

Related Public Records

Same Entity

Tianjin Ethylene Oxide Sterilization 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
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

Registration Number	Establishment Name	Location
3010273872	Synergy Health AST, SRL	Alajuela, CR
3012179728	St. Jude Medical	Roseville, MN, US
2182208	MEDTRONIC, INC.	Mounds View, MN, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
1721686	Sterigenics U.S., LLC	Santa Teresa, NM, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037050339. Last updated year: 2026. Please use registration number 3037050339 when referencing this establishment in official correspondence.