Quantum Perfusion
by Spectrum Medical SRL 2 variants
Ref CP37V-V0Model Quantum Perfusion Centrifugal Blood Pump
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number18051160300614 | Date21 May 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number8051160300037R8 18051160300614 | Date29 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Quantum Perfusion EUDAMEDQuantum Perfusion Centrifugal Blood Pump CP37 GUDID
- Generic Name
- Cardiopulmonary bypass system centrifugal pump
- Model / Reference
- Quantum Perfusion Centrifugal Blood Pump, CP37V-V0
- Primary DI / UDI-DI
- 18051160300614
- Basic UDI-DI
- 8051160300037R8
- FDA Product Code
- KFM
- EMDN Code
- C030199 Extracorporeal and assisted circulation devices - other
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.4360
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- IT-MF-000009234
Other devices from Spectrum Medical SRL
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No