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MatriXX ONE E6020060

by IBA Dosimetry GmbH

Ref DP41-050

MatriXX ONE E6020060 is a device classified as Class IIb in the EU and Class II in the US made by IBA Dosimetry GmbH, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-EIBAE60200600), cleared under FDA 510(k) K031634 on 29 Aug 2003 and listed in FDA GUDID since 15 May 2017 (UDI-DI EIBAE60200600), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031634

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EIBAE60200600 Basic UDI-DI EIBAE60200600UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEIBAE60200600 UDI-DI Date15 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031634 Date29 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-EIBAE60200600 registered 6 Oct 2026 Active
  • FDA 510(k) K031634 decided 29 Aug 2003 Active
  • FDA GUDID UDI-DI EIBAE60200600 listed 15 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031634
  2. Listed FDA GUDID EIBAE60200600
  3. Registered EUDAMED B-EIBAE60200600

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MatriXX ONE
Generic name
Accelerator system quality assurance device
Model / reference
DP41-050 EUDAMED
E6020060 GUDID
Primary DI / UDI-DI
EIBAE60200600
Basic UDI-DI
B-EIBAE60200600
510(k) Number
FDA product code
IYE
EMDN code
Z119002 Dosimeters
GMDN term
Accelerator system quality assurance device
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DP41-050
GUDID
E6020060
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Accelerator system quality assurance device

Cleared under the same submission (K031634)

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from IBA Dosimetry GmbH

See all devices from IBA Dosimetry GmbH →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)