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Sign in to claim this brandSORIN GROUP ITALIA SRL
US
Last updated May 23, 2026
What SORIN GROUP ITALIA SRL makes
The company manufactures extracorporeal life support devices, including cannulae for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO), such as arterial and coronary perfusion cannulae, as well as drainage cannulae. It also produces ECMO oxygenators, autotransfusion systems for blood component processing and collection, including tubing and reservoirs, and vascular irrigation cannulae for coronary arteries. Additional products include vascular irrigation cannulae and accessories for blood autotransfusion procedures.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a US-based presence, adhering to applicable regulatory requirements for medical devices in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sorin Group Italia SRL manufacture?
Sorin Group Italia SRL specializes in extracorporeal life support devices, including cannulae for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Their product line covers arterial and coronary perfusion cannulae, drainage cannulae, ECMO oxygenators, autotransfusion systems (such as blood collection containers and processing sets), blood autotransfusion tubing, cardiotomy reservoirs, and vascular irrigation cannulae for coronary arteries. These devices are designed to support critical cardiac and circulatory procedures.
Where is Sorin Group Italia SRL based, and how does this affect its regulatory compliance?
Sorin Group Italia SRL operates with a presence in the United States, meaning its devices must comply with FDA regulations applicable to medical devices marketed there. The company’s products are subject to FDA classification and registration requirements, including listing in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and regulatory oversight for devices like cannulae, oxygenators, and autotransfusion systems.
Which regulatory registries or databases list Sorin Group Italia SRL’s devices?
Sorin Group Italia SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the United States, ensuring transparency and compliance with FDA requirements. The UDI system helps healthcare providers and regulators verify device details, including classification and manufacturing information.
How are Sorin Group Italia SRL’s devices classified under FDA regulations?
Sorin Group Italia SRL’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use—for example, cannulae and oxygenators for ECMO or cardiopulmonary bypass are typically Class II due to their critical role in patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 442126587
Catalogue (445)
Page 7 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Protek Solo | 5130-1717 | FDA UDI | Class II | Active |
| Xtra | BOWL SET X/55 | FDA UDI | Class II | Active |
| Brat 2 | STANDBY COLLECTION SET - 30 µm | FDA UDI | Class II | Active |
| DAC Cardiotomy | D714 Holder | FDA UDI | Class I | Active |
| Xtra | COLLECTION SET BX CARDIO | FDA UDI | Class II | Active |
| Arterial Cannula | A212-65C | FDA UDI | Class II | Active |
| PureFlex Arterial Cannulae | RA22-1SB Straight collar tip | FDA UDI | Class II | Active |
| PureFlex Arterial Cannulae | RA18-1BC Bent collar tip | FDA UDI | Class II | Active |
| Vanguard | D924P BLOOD DELIVERY SET 4:1 | FDA UDI | Class II | Active |
| Kids | D130 NEONATAL ART.FILTER PH+PURGE LINE | FDA UDI | Class II | Active |
| Inspire | 8M | FDA UDI | Class II | Active |
| Sinergy and Mini Bag CPB | Holder | FDA UDI | Class I | Active |
| Xtra | XRES T BLOOD COLLECTION RESERVOIR | FDA UDI | Class II | Active |
| Arterial Cannula | A232-80B | FDA UDI | Class II | Active |
| Lilliput | D901 MODULE | FDA UDI | Class II | Active |
| Reservoir | D754 DIDECO VENOMIDICARD | FDA UDI | Class II | Active |
| Xtra | PROCED.SET BX 225 - 120µm | FDA UDI | Class II | Active |
| Arterial Cannula | A282-80A | FDA UDI | Class II | Active |
| Xtra | COLLECTION SET BX-120 µm | FDA UDI | Class II | Active |
| Paediatric Arterial Cannula | A272-40N | FDA UDI | Class II | Active |
| Bmr | 1900 PH.I.S.I.O. | FDA UDI | Class II | Active |
| Xtra | XRES T BLOOD COLL.RESERVOIR W.CARDIO KIT | FDA UDI | Class II | Active |
| PureFlex Arterial Cannulae | RA22-2BB Bent flange tip | FDA UDI | Class II | Active |
| Arterial Cannula | A222-30B | FDA UDI | Class II | Active |
| Suction tip | SU-12502 | FDA UDI | Class II | Active |
| Paediatric Venous Cannula | V132-20 | FDA UDI | Class II | Active |
| Xtra | PROCEDURE SET TX/175 | FDA UDI | Class II | Active |
| Intracardiac Sucker | S351-70 | FDA UDI | Class II | Active |
| Xtra | PROCEDURE SET TX/225 | FDA UDI | Class II | Active |
| Brat 2 | PROCEDURE SET - 30 µm/135 ml | FDA UDI | Class II | Active |
| PureFlex Arterial Cannulae | RA24-2BC Bent flange tip | FDA UDI | Class II | Active |
| Protek Solo | 5140-6221 | FDA UDI | Class II | Active |
| Xtra | WASTE BAG X 10 L | FDA UDI | Class II | Active |
| Arterial Cannula | A211-45N | FDA UDI | Class II | Active |
| Xtra | XRES B BLOOD COLLECTION RESERVOIR | FDA UDI | Class II | Active |
| PureFlex Arterial Cannulae | RA22-1SP Straight collar tip | FDA UDI | Class II | Active |
| Vanguard | D924S BLOOD DELIVERY SET 4:1 | FDA UDI | Class II | Active |
| Autotransfusion Reservoir | BT844 + CYA | FDA UDI | Class II | Active |
| Coronary Perfusion Cannula | P618-45 | FDA UDI | Class II | Active |
| Preassembled Surgical Wash Set | COD.740C-125 ML BOWL | FDA UDI | Class II | Active |
| Coronary Perfusion Cannula | P616-40 | FDA UDI | Class II | Active |
| Inspire | SVR 1200 | FDA UDI | Class II | Active |
| Brat 2 | PROCEDURE SET - 120 µm/135 ml | FDA UDI | Class II | Active |
| Arterial Cannula | A291-80B | FDA UDI | Class II | Active |
| Arterial Cannula | A211-30N | FDA UDI | Class II | Active |
| Venous Cannula | V152-32 | FDA UDI | Class II | Active |
| Protek Solo | 5140-6217 | FDA UDI | Class II | Active |
| Arterial Cannula | A212-30B | FDA UDI | Class II | Active |
| Arterial Cannula | A232-38B | FDA UDI | Class II | Active |
| Aortic-Root Cannula | R501-15 | FDA UDI | Class II | Active |
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