Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011241266

FEI Number

3011241266

Entity Name

Freudenberg Medical, SRL

City/State/Country

La Garita Alajuela, CR

Establishment Address

Zona Franca Coyol, Calle 4, Av. 0, Edificio B17, La Garita Alajuela 20113, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Freudenberg Medical Ireland Limited (Owner Number: 10047567)

Owner / Operator Contact Address

IDA Business and Technology Park, Carrick-on-Shannon, Leitrim, Ireland, IE-LM N41 N8C9, 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
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-09-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-09-04
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-03-10

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
3008328690	Freudenberg Medical Ireland Limited	Leitrim, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011241266. Last updated year: 2026. Please use registration number 3011241266 when referencing this establishment in official correspondence.