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Barco

by Barco NV 16 variants

Ref K9301101A2XModel Pathology Display

Barco (K9301101A2X) is a device classified as Class IIa in the EU and Class II in the US made by Barco NV, registered in EUDAMED on 28 Oct 2024 (Basic UDI-DI 5415334_Pathology_X4) and listed in FDA GUDID since 19 Dec 2023 (UDI-DI 05415334044371), 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_Pathology_X4 Basic UDI-DI 05415334044371UDI-DIDate28 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05415334044371 UDI-DI Date19 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415334_Pathology_X4 registered 28 Oct 2024 Active
  • FDA GUDID UDI-DI 05415334044371 listed 19 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05415334044371
  2. Registered EUDAMED 5415334_Pathology_X4

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  • Withdrawn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
Digital pathology image display unit IVD
Model / Ref / Catalog
Pathology Display, K9301101A2X, MDPC-8127
Primary DI / UDI-DI
05415334044371
Basic UDI-DI
5415334_Pathology_X4
FDA product code
PSY
EMDN code
Z11069082 Various digital bioimaging management instruments - software accessories
GMDN term
Digital pathology image display unit IVD
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.3700
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
Pathology Display
K9301101A2X
GUDID
MDPC-8127
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 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES.

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Properties

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