Freudenberg Medical Hemoteq

FDA Device Registration & Listing · Wurselen North Rhine-Westphalia, DE · Registration 3005969022

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
3005969022
FEI Number
3005969022
Entity Name
Freudenberg Medical Hemoteq
City/State/Country
Wurselen North Rhine-Westphalia, DE
Establishment Address
Adenauerstasse 15, Wurselen North Rhine-Westphalia 52146, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hemoteq (Owner Number: 10078693)
Owner / Operator Contact Address
Adenauerstasse 15, Wurselen, DE-NW 52146, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ranger™ Paclitaxel-Coated PTA Balloon Catheter AGENTTM Paclitaxel-Coated Balloon Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2020-11-02
OOB Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter Unknown Class 3 N/A 2024-04-19

Official Correspondent

Ralph Engbrodt

US Agent Details

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

Related Public Records

Same Entity

Hemoteq
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005969022. Last updated year: 2026. Please use registration number 3005969022 when referencing this establishment in official correspondence.
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