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Quantum PureFlow

by Spectrum Medical SRL 3 variants

Ref HX11V-S0WModel Quantum PureFlow Standard Heat Exchanger W

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

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 Number18051160302236 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8051160300006QV Basic UDI-DI 18051160302236UDI-DIDate5 Jun 2024RegisteredStatusActive

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

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3327-2026 FDA Class II initiated 17 Jul 2026
    • Ongoing Z-3328-2026 FDA Class II initiated 17 Jul 2026

    Due to blood-to-glycol leak in the heat exchanger.

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  • Withdrawn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 PureFlow EUDAMED
Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 W GUDID
Generic Name
Cardiopulmonary bypass system heat exchanger, single-use
Device Name
Standard Heat Exchanger High Flow 3/8 W
Model / Reference
Quantum PureFlow Standard Heat Exchanger W, HX11V-S0W
Primary DI / UDI-DI
18051160302236
Basic UDI-DI
8051160300006QV
510(k) Number
FDA Product Code
DTR
EMDN Code
C030199 Extracorporeal and assisted circulation devices - other
GMDN Term
Cardiopulmonary bypass system heat exchanger, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4240
EU market of registration
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