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Quantum SuperPac

by Spectrum Medical SRL 5 variants

Ref SPCCPGD-D1, SPE200C-B1, SPC200A-D2, SP05E-A0, SPE200F-B1, SPCCPGD-D5, SPC160A-D3, SPCCPGD-D6Model Quantum SuperPac Cardioplegia, Quantum SuperPac Long Term, Quantum SuperPac, Quantum SuperPac Long Term Tubing Set

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18051160303103 UDI-DI Date22 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8051160300303R6 Basic UDI-DI Date29 Aug 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.

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  • Withdrawn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 SuperPac EUDAMED
Quantum SuperPAC CPB – 1/2 Venous with AV Bridge GUDID
Quantum SuperPAC Cardioplegia - Clamp System GUDID
Quantum SuperPAC Cardioplegia - Quick System GUDID
Quantum SuperPAC CPB – 3/8 Venous GUDID
Generic Name
Cardiopulmonary bypass system blood tubing set
Cardiopulmonary bypass system heat exchanger, single-use
Device Name
Quantum SuperPAC Cardioplegia - Master Follower
Quantum SuperPAC Long Term - High Flow
Quantum SuperPAC CPB - 1/2 Venous
Quantum SuperPac Long Term High Flow Tubing Set - SP05E-A0
Model / Reference
Quantum SuperPac Cardioplegia, SPCCPGD-D1, Quantum SuperPac Long Term, SPE200C-B1, SPC200A-D2, Quantum SuperPac, Quantum SuperPac Long Term Tubing Set, SP05E-A0, SPE200F-B1, SPCCPGD-D5, SPC160A-D3, SPCCPGD-D6
Primary DI / UDI-DI
18051160303103, 18051160303073, 18051160303134, 18051160302700, 18051160302915, 18051160303301, 18051160303141, 18051160303318
Basic UDI-DI
8051160300303R6, 8051160300280RK, 8051160300273RN, 8051160300105QY
EMDN Code
C030102, C03010101
GMDN Term
Cardiopulmonary bypass system blood tubing set
Cardiopulmonary bypass system heat exchanger, single-use
Device Class
Class IIa
EU market of registration
Italy
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
IT-MF-000009234

Other devices from Spectrum Medical SRL

See all devices from Spectrum Medical SRL →

Properties

  • Sterile
  • Single Use
  • Convenience Kit
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No