Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005280205

FEI Number

3005280205

Entity Name

TIANJIN JPY ION-TECH. CO., LTD.

City/State/Country

TIANJIN, CN

Establishment Address

11 ZHONGHUAN RD. SOUTH, TIANJIN PORT FREE TRADE ZONE (AIRPORT ECONOMIC ZONE), TIANJIN 300308, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

TIANJIN JPY ION-TECH. CO., LTD. (Owner Number: 9075860)

Owner / Operator Contact Address

11 ZHONGHUAN RD. SOUTH, TIANJIN PORT FREE TRADE ZONE (AIRPORT ECONOMIC ZONE), TIANJIN, CN-TJ 300308, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Needles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-08-01
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-07-24

Official Correspondent

Juan Du

US Agent Details

Charles Shen Business: MANTON BUSINESS & TECHNOLOGY SERVICES, LLC Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

TIANJIN JPY ION-TECH. 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3029952419	DIAMINY MEDICAL AESTHETICS	Shanghai, CN
3020664622	Pneumeric, Inc.	Luverne, MN, US
3005748921	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN
9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005280205. Last updated year: 2026. Please use registration number 3005280205 when referencing this establishment in official correspondence.