Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019677404

FEI Number

3019677404

Entity Name

Quasar MED IE (QIE) Limited

City/State/Country

Galway Connaught, IE

Establishment Address

Ballybrit Upper Industrial Estate, Monivea Road, Galway Connaught H91 XP49, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Quasar MED IE (QIE) Limited (Owner Number: 10094010)

Owner / Operator Contact Address

Quasar MED IE (QIE) Limited, Galway, IE-C 11598, IE

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
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-09-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Quasar MED IE (QIE) Limited

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
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

Similar Registrations

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3010273872	Synergy Health AST, SRL	Alajuela, CR
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
3005994106	Creagh Medical Ltd.	Co. Galway, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019677404. Last updated year: 2026. Please use registration number 3019677404 when referencing this establishment in official correspondence.