Data / Medical devices / Italy / Eurosets s.r.l.
Eurosets s.r.l.: FDA-registered device maker in Medolla Modena, Italy, 8 510(k) clearances
Eurosets s.r.l. is registered with the FDA (registration 3003752502) in Medolla Modena, Italy. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003752502
- Address
- Strada Statale 12, n. 143, Medolla Modena, Italy, 41036
- Owner or operator
- Eurosets (10036608)
- Roles
- Manufacturer
- First device listed
- May 18, 2011
- Registered through
- 2027
- Brand names listed
- AMG PMP PEDIATRIC, Eurosets Reinforced Dual Lumen Catheter, FIRM HOLDER LONG, FLEXIBLE HOLDER LONG, FLEXIBLE HOLDER SHORT, HEAD FIX HOLDER SHORT, Horizon AF Plus System (Integrated A.L.One AF Plus OXYGENATOR and Horizon CVR), Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Manufacturer | accessdata.fda.gov |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2026 | K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| December 12, 2025 | K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| November 24, 2025 | K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| December 10, 2021 | K202510 | AMG PMP Infant | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| April 1, 2021 | K202206 | AMG PMP Pediatric | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| February 6, 2015 | K141492 | ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
| July 26, 2012 | K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER | DWF | Substantially Equivalent | Origen Biomedical, Inc. | accessdata.fda.gov |
| February 15, 2011 | K102109 | ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 | DTZ | Substantially Equivalent | Eurosets S.R.L | accessdata.fda.gov |
Compare with other makers
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
- All makers of Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- All makers of Reservoir, Blood, Cardiopulmonary Bypass
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Accessory Equipment, Cardiopulmonary Bypass
Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.