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Coronis Uniti

by Barco NV 2 variants

Ref K9301680AModel Radiology Display

Coronis Uniti (K9301680A) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code PGY, Display, diagnostic radiology; EMDN category bioimaging diagnostic report viewing monitors) made by Barco NV, registered in EUDAMED on 28 Oct 2024 (Basic UDI-DI 5415334_Uniti_2D) and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 05415334000018), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415334_Uniti_2D Basic UDI-DI 05415334000018UDI-DIDate28 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05415334000018 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415334_Uniti_2D registered 28 Oct 2024 Active
  • FDA GUDID UDI-DI 05415334000018 listed 30 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05415334000018
  2. Registered EUDAMED 5415334_Uniti_2D

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  • Withdrawn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

Generic name
Radiology picture archiving and communication system workstation
Device name
Mdmc-12133
Model / Ref / Catalog
Radiology Display, K9301680A, MDMC-12133
Primary DI / UDI-DI
05415334000018
Basic UDI-DI
5415334_Uniti_2D
FDA product code
PGY
EMDN code
Z11900801 Bioimaging diagnostic report viewing monitors
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Radiology Display
K9301680A
GUDID
MDMC-12133
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
BE-MF-000000690

Similar devices in this category

Other devices filed under BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS.

Other devices from Barco NV

See all devices from Barco NV →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)