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Quantum Perfusion Capnometer Line Set CAP-SP1

by Spectrum Medical Limited EUDAMEDGUDID

Active European Union

Ref CAP-SP1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number18051160302137 UDI-DIDate21 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8051160300136RB Basic UDI-DIDate4 Mar 2024RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Quantum Perfusion EUDAMED
Quantum Perfusion Capnometer Line Set GUDID
Generic Name
Gas-sampling/monitoring respiratory tubing, single-use
Model / Reference
CAP-SP1
Primary DI / UDI-DI
18051160302137
Basic UDI-DI
8051160300136RB
FDA Product Code
KRI
EMDN Code
C030199 Extracorporeal and assisted circulation devices - other
GMDN Term
Gas-sampling/monitoring respiratory tubing, single-use
Device Class
Class I
Regulation Number
870.4200
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Other devices from Spectrum Medical Limited

See all devices from Spectrum Medical Limited →

Properties

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

Other properties (19)

  • Sterile: 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