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HexaVue-SLC 1.0

by Black Diamond Video, Inc.

Part of a family of 6 devices: see the family page

Ref XQHLC1Model ORI - Hexavue

HexaVue-SLC 1.0 (XQHLC1) is a device classified as Class I in the EU and Class II in the US made by Black Diamond Video, Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0724495RMHEXAVUEORI7C) and listed in FDA GUDID since 4 Sep 2020 (UDI-DI 00724995198497), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724495RMHEXAVUEORI7C Basic UDI-DI 00724995198497UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995198497 UDI-DI Date4 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724495RMHEXAVUEORI7C registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995198497 listed 4 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995198497
  2. Registered EUDAMED 0724495RMHEXAVUEORI7C

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  • Withdrawn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

Trade name
HexaVue
Generic name
Operating room audiovisual data/device management system
Device name
ORI - Hexavue
Model / Ref / Catalog
ORI - Hexavue, XQHLC1, HexaVue-SLC 1.0
Primary DI / UDI-DI
00724995198497
Basic UDI-DI
0724495RMHEXAVUEORI7C
FDA product code
FTA
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 EUDAMED
Class II GUDID
Regulation number
878.4580
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ORI - Hexavue
XQHLC1
GUDID
HexaVue-SLC 1.0
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Operating room audiovisual data/device management system application software

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE.

Other devices from Black Diamond Video, Inc.

See all devices from Black Diamond Video, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)