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Quantum PureFlow

by Spectrum Medical SRL

Ref CONN-HX2Model Quantum PureFlow Connector Adaptor Kit CPC

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8051160300129RE Basic UDI-DI 08051160301577UDI-DIDate19 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08051160301577 UDI-DI Date18 May 2022ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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 KIT CPC - Hansen Connector Adaptor GUDID
Generic Name
Cardiopulmonary bypass system heat exchanger, single-use
Device Name
Quantum PureFlow Connector Adaptor Kit CPC - Hansen Connector Adaptor
Model / Reference
Quantum PureFlow Connector Adaptor Kit CPC, CONN-HX2
Primary DI / UDI-DI
08051160301577
Basic UDI-DI
8051160300129RE
FDA Product Code
KRI
EMDN Code
C030180 Extracorporeal and assisted circulation devices - accessories
GMDN Term
Cardiopulmonary bypass system heat exchanger, single-use
Device Class
Class I
Regulation Number
870.4200
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IT-MF-000009234

Other devices from Spectrum Medical SRL

See all devices from Spectrum Medical SRL →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • 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
  • Serial Number: No
  • Manufacturing Date: No