Eurosets s.r.l.

FDA Device Registration & Listing · Medolla Modena, IT · Registration 3003752502

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
3003752502
FEI Number
3003752502
Entity Name
Eurosets s.r.l.
City/State/Country
Medolla Modena, IT
Establishment Address
Strada Statale 12, n. 143, Medolla Modena 41036, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Eurosets (Owner Number: 10036608)
Owner / Operator Contact Address
Strada Statale 12,143, Medolla (MO), IT-MO 41036, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K113869
PMA Number
N/A

All Registered Proprietary Names

AMG PMP PEDIATRIC FIRM HOLDER LONG FLEXIBLE HOLDER SHORT FLEXIBLE HOLDER LONG Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir Horizon AF Plus System (Integrated A.L.One AF Plus OXYGENATOR and Horizon CVR) Eurosets Reinforced Dual Lumen Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2021-04-12
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2019-01-31
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2026-01-16
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2026-01-16
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2026-01-16
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2026-01-16
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2022-07-05
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2011-05-18
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2026-01-16
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2026-01-16
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2026-01-16
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2026-01-16
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2016-07-22
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2023-06-16

Official Correspondent

Katia Vescovini

US Agent Details

Sebastian Feye Business: Accurate Consultants Inc. Email: sebastian@accuratefdaconsulting.com Phone: (619) 5170673

Related Public Records

Same Entity

Eurosets
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
K862357 3M Health Care, Sarns MODIFIED CARDIOTOMY RESERVOIR 5M1470 1986-08-19
K914791 Gish Biomedical, Inc. GISH ARTERIAL FILTER 1993-04-06
K790435 Surgikos, Inc. INTERSEPT* BLOOD FILTER W/ TUBING BYPASS 1979-03-27
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003752502. Last updated year: 2026. Please use registration number 3003752502 when referencing this establishment in official correspondence.
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