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Quantum Perfusion

by Spectrum Medical SRL 2 variants

Ref CP22V-VPL, VT200-E1L, VT75-E1L, VT200-C2, VT160-C2, CP20V-NGL, VT75-C2, CP22V-NGLModel Quantum Perfusion Centrifugal Blood Pump with Integrated Pressure Sensors Long Term, Quantum Perfusion Blood Oxygenator Long Term, Quantum Perfusion Blood oxygenator with integrated AF

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08051160301089 UDI-DI Date11 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8051160300044R5 Basic UDI-DI Date19 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Quantum Perfusion EUDAMED
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2 GUDID
Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 GUDID
Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2 GUDID
Generic Name
Extracorporeal membrane oxygenator
Device Name
Quantum Perfusion Centrifugal Blood Pump with Integrated Pressure Sensors Long Term CP22
Quantum Perfusion Blood Oxygenator Long Term VT200-E1L
Model / Reference
Quantum Perfusion Centrifugal Blood Pump with Integrated Pressure Sensors Long Term, CP22V-VPL, Quantum Perfusion Blood Oxygenator Long Term, VT200-E1L, VT75-C2, VT75-E1L, Quantum Perfusion Blood oxygenator with integrated AF, VT200-C2, VT160-C2, CP20V-NGL, CP22V-NGL
Primary DI / UDI-DI
08051160301089, 08051160300976, 18051160301796, 18051160301826, 18051160300706, 18051160300768, 18051160302984, 18051160303004
Basic UDI-DI
8051160300044R5, 8051160300204R3, 8051160300198RZ
510(k) Number
FDA Product Code
DTZ
EMDN Code
C030199, C03010102
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4350
EU market of registration
Germany
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000009234

Other devices from Spectrum Medical SRL

See all devices from Spectrum Medical SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

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