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QUANTUM™ CT Overlay RT-4550GER2

by Qfix

Part of a family of 59 devices: see the family page

Ref RT-4550GER2Model Couchtops, Overlays, and Multipurpose Devices

QUANTUM™ CT Overlay RT-4550GER2 is a device classified as Class I in the EU and Class II in the US made by Qfix, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 8419621COUCHTOPSMPD6F) and listed in FDA GUDID since 18 Oct 2022 (UDI-DI 10841962111291), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8419621COUCHTOPSMPD6F Basic UDI-DI 10841962111291UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841962111291 UDI-DI Date18 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8419621COUCHTOPSMPD6F registered 22 May 2026 Active
  • FDA GUDID UDI-DI 10841962111291 listed 18 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10841962111291
  2. Registered EUDAMED 8419621COUCHTOPSMPD6F

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  • Withdrawn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™ CT Overlay
Generic name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
RT-4550GER2, Couchtops, Overlays, and Multipurpose Devices
Primary DI / UDI-DI
10841962111291
Basic UDI-DI
8419621COUCHTOPSMPD6F
FDA product code
JAI
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Indexed-immobilization patient positioning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5770
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 207 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Indexed-immobilization patient positioning system

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Qfix

See all devices from Qfix →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)