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Visual Guidance 1573972

by Elekta Solutions AB

Ref 1573972

Visual Guidance 1573972 is a device classified as Class I in the EU and Class II in the US made by Elekta Solutions AB, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 073402015BUDI000000014PG) and listed in FDA GUDID since 28 Apr 2026 (UDI-DI 07340201503737), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number073402015BUDI000000014PG Basic UDI-DI 07340201503737UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07340201503737 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 073402015BUDI000000014PG registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 07340201503737 listed 28 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07340201503737
  2. Registered EUDAMED 073402015BUDI000000014PG

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  • Withdrawn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
Visual Guidance
Generic name
Breath-hold system remote display
Device name
Accessories to Unity (Active Devices)
Model / Ref / Catalog
1573972
Primary DI / UDI-DI
07340201503737
Basic UDI-DI
073402015BUDI000000014PG
FDA product code
IYE
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Breath-hold system remote display
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

Other devices from Elekta Solutions AB

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Properties

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