MEDISIZE IRELAND LTD.

FDA Device Registration & Listing · LETTERKENNY Donegal, IE · Registration 8020864

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8020864
FEI Number
3005737257
Entity Name
MEDISIZE IRELAND LTD.
City/State/Country
LETTERKENNY Donegal, IE
Establishment Address
HIGH ROAD, LETTERKENNY Donegal --, IE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Phillips-Medisize, LLC (Owner Number: 2183833)
Owner / Operator Contact Address
2202 Carmichael Rd, Hudson, WI 54016, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LungFit PH NO2 Filter Lenire TECA MYOJECT - LUER LOCK - DISPOSABLE NEEDLE ELECTRODE CT ExpresTM 3D Contrast Media Delivery System Luer Elbow 7.6mm Port Kit (90016) 10mm Gas Sample Adaptor Kit (90006) 22mm Gas Sample Adaptor Kit (90017) 15mm Gas Sample Adaptor Kit (90007) TECA Myoject - Luer lock - Disposable hypodermic needle electrode Bo-ject® DHN Disposable Hypodermic Needle Electrode

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QTB Nitric Oxide Generator And Delivery System Unknown Class 3 N/A 2022-11-17
QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus Ear, Nose, Throat Class 2 874.3410 2023-03-08
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2014-11-13
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2017-12-18
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2025-09-24
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2017-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Julie Weghorn Business: Phillps-Medisize, LLC Email: julie.weghorn@molex.com Phone: (715) 8315443

Related Public Records

Same Entity

Phillips-Medisize, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013025177 Phillips-Medisize Healthcare (Suzhou) CO., LTD Suzhou Jiangsu, CN
2134944 PHILLIPS-MEDISIZE, LLC New Richmond, WI, US
3011397539 Molex Little Rock Maumelle, AR, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K152984 Bio Protech, Inc. Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes 2016-06-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020864. Last updated year: 2026. Please use registration number 8020864 when referencing this establishment in official correspondence.
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