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Quantum LSC_HRF

by Spectrum Medical Limited

Ref LSC_HRF

Quantum LSC_HRF is a Class I device made by Spectrum Medical Limited, registered in EUDAMED on 10 Dec 2025 (Basic UDI-DI 506043442LSCDH) and listed in FDA GUDID since 22 Dec 2023 (UDI-DI 05060434423962), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506043442LSCDH Basic UDI-DI 05060434423962UDI-DIDate10 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060434423962 UDI-DI Date22 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506043442LSCDH registered 10 Dec 2025 Active
  • FDA GUDID UDI-DI 05060434423962 listed 22 Dec 2023 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 05060434423962
  2. Registered EUDAMED 506043442LSCDH

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  • Withdrawn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
Generic name
Sensor holder, single-use
Device name
Quantum Reservoir Level Sensor Cradle Curved Taper (Box of 100)
Model / Ref / Catalog
LSC_HRF
Primary DI / UDI-DI
05060434423962
Basic UDI-DI
506043442LSCDH
FDA product code
KRI
EMDN code
C030199 Extracorporeal and assisted circulation devices - other
GMDN term
Sensor holder, single-use
Device class
Class I
Regulation number
870.4200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sensor holder, single-use

Similar devices in this category

Other devices filed under EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER.

Other devices from Spectrum Medical Limited

  • Quantum QMCDM

    Class II

  • Quantum QFS3-ST-075

    Class II

  • Quantum QCD37

    Class II

  • Quantum QFS3-RA-150

    Class II

See all devices from Spectrum Medical Limited →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)