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MultiFix 2

by Qfix EUDAMEDGUDID

Active European Union

Ref RT-5411Model Couchtops, Overlays, and Multipurpose Devices

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841439115305 UDI-DIDate4 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8419621COUCHTOPSMPD6F Basic UDI-DIDate22 May 2026RegisteredStatusActive

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  • Withdrawn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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
Couchtops, Overlays, and Multipurpose Devices, RT-5411
Primary DI / UDI-DI
00841439115305
Basic UDI-DI
8419621COUCHTOPSMPD6F
510(k) Number
FDA Product Code
IYE
EMDN Code
Z12011299 Patient positioning instruments – other
GMDN Term
Indexed-immobilization patient positioning system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
Market of Registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002762
Authorised representative
Advena SRL IT-AR-000051131

Other devices from Qfix

See all devices from Qfix →

Properties

  • Reusable
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No