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Vividimage D HD RLM27HD3

by Black Diamond Video, Inc.

Ref RLM27HD3Model Sonic Manufacturing

Vividimage D HD RLM27HD3 is a Class I device made by Black Diamond Video, Inc., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 0724995RMVIMAGED27SON9U) and listed in FDA GUDID since 31 Mar 2021 (UDI-DI 00724995195069), 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 Number0724995RMVIMAGED27SON9U Basic UDI-DI 00724995195069UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995195069 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995RMVIMAGED27SON9U registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995195069 listed 31 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995195069
  2. Registered EUDAMED 0724995RMVIMAGED27SON9U

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  • Withdrawn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 EUDAMED
Vividimage D HD GUDID
Generic name
Image display unit, colour
Device name
Sonic Manufacturing
Model / Ref / Catalog
RLM27HD3, Sonic Manufacturing
Primary DI / UDI-DI
00724995195069
Basic UDI-DI
0724995RMVIMAGED27SON9U
FDA product code
KQM
EMDN code
Z129080 Various instruments for functional exploration and therapeutic interventions - hardware accessories
GMDN term
Image display unit, colour
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Image display unit, colour

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIES.

Other devices from Black Diamond Video, Inc.

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Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)