Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012964172

FEI Number

3012964172

Entity Name

ELITE MEDTEK(JIANGSU) CO., LTD

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

Building 5, Tianning Zhizao Park, No. 5 Beitanghe East Road, Tianning District, Changzhou City Jiangsu 213003, CN

Establishment Type(s)

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

Owner / Operator

Elite Medtek(Jiangsu) Co., Ltd (Owner Number: 10056257)

Owner / Operator Contact Address

Building 5, Tianning Zhizao Park, No. 5 Beitanghe East Road, Tianning District, Changzhou City, CN-JS 213003, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Inflation Device Maniflods, stopcock, adaptor Inflation Device, Model EM-lD-D40 Inflation Device.Model EM-lD-M40 Inflation Device, Model EM-lD-D30S Inflation Device, Model EM-lD-M5 Inflation Device, Model EM-lD-D30 Inflation Device, Model EM-lD-M30S Inflation Device, Model EM-lD-M30 Inflation Device, Model EM-lD-D40S Inflation Device, Model EM-lD-M40S Inflation Device, Model EM-lD-D15S Inflation Device, Model EM-lD-D5S Inflation Device, Model EM-lD-M15 Inflation Device, Model EM-lD-D5 Disposable Inflation Device, BID-15-60-1 Inflation Device,Model EM-lD-M15S Inflation Device, Model EM-lD-M5S Inflation Device, Model EM-lD-D15 Inflation kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-02-07
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-12-01
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-11-21
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2019-12-04

Official Correspondent

Ashly Lu

US Agent Details

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

Related Public Records

Same Entity

Elite Medtek(Jiangsu) 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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012964172. Last updated year: 2026. Please use registration number 3012964172 when referencing this establishment in official correspondence.