Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008328690

FEI Number

3008328690

Entity Name

Freudenberg Medical Ireland Limited

City/State/Country

Leitrim, IE

Establishment Address

IDA Business & Technology Park, Carrick On Shannon, CO, Leitrim, Leitrim N41 N8C9, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Freudenberg Medical Ireland Limited (Owner Number: 10031914)

Owner / Operator Contact Address

IDA Business and Technology Park, Carrick-on-Shannon, IE-LM 0000, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IRIS Uretal Kit Infravision Universal Ureteral Kit Infravision Universal Ureteral kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Gastroenterology, Urology	Class 2	876.4020	2016-08-16
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Gastroenterology, Urology	Class 2	876.4020	2024-04-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-06-13

Official Correspondent

Mary Prunty

US Agent Details

Rhonda Kops Business: Freudenberg Medical LLC Email: regulatoryaffairs@freudenbergmedical.com Phone: (262) 8040860

Related Public Records

Same Entity

Freudenberg Medical Ireland Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011241266	Freudenberg Medical, SRL	La Garita Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

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

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3008132398	Sterigenics UK Limited	Alfreton Derbyshire, GB
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
3007303113	FONG'S ENGINEERING & MANUFACTURING PRIVATE LIMITED	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008328690. Last updated year: 2026. Please use registration number 3008328690 when referencing this establishment in official correspondence.