FDA Registration
Active
🇮🇹 Italy
Eurosets s.r.l.
Reg #: 3003752502
·
FEI: 3003752502
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Eurosets s.r.l.
- Registration Number
- 3003752502
- FEI Number
- 3003752502
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Strada Statale 12, n. 143
- City
- Medolla Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K202206
Owner / Operator
- Firm Name
- Eurosets
- Operator Number
- 10036608
- Address
- Strada Statale 12,143
- City
- Medolla (MO)
- State
- Modena
- Postal Code
- 41036
- Country
- IT
- Correspondent
- Katia Vescovini
US Agent
- Business Name
- Accurate Consultants Inc.
- Contact Name
- Sebastian Feye
- Address
- 3234 Ibis Street
- City
- San Diego
- State
- CA
- ZIP
- 92103
- Country
- US
- [email protected]
- Phone
- 619 5170673
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2021-04-12 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2019-01-31 |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | Class 2 | Cardiovascular | No | 2026-01-16 |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | Class 2 | Cardiovascular | No | 2026-01-16 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2026-01-16 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2023-06-16 |
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
Establishment Types
Manufacture Medical Device