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Vividimage D HD

by STERIS Corporation EUDAMEDGUDID

Active European Union

Ref XEHFSLCAMCModel Hexavue Focus

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995RMHEXAVUEFOCUSTH Basic UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995245061 UDI-DIDate17 Oct 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Vividimage D HD EUDAMED
HexaVue GUDID
Generic Name
Operating room audiovisual data/device management system
Model / Ref / Catalog
Hexavue Focus, XEHFSLCAMC
Primary DI / UDI-DI
00724995245061
Basic UDI-DI
0724995RMHEXAVUEFOCUSTH
FDA Product Code
KQM
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
GMDN Term
Operating room audiovisual data/device management system
Device Class
Class I
Regulation Number
878.4160
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000018223
Authorised representative
STERIS Ireland Ltd IE-AR-000010065

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No