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BladderScan® Tissue-Equivalent Phantom

by Verathon Inc

Ref 0620-0068

BladderScan Tissue-Equivalent Phantom (0620-0068) is an ultrasound system quality assurance device (EU MDR Class I; FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Verathon Inc, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0879123000015X4) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00879123001962), active as of 8 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0879123000015X4 Basic UDI-DI 00879123001962UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123001962 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0879123000015X4 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00879123001962 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00879123001962
  2. Registered EUDAMED 0879123000015X4

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  • Withdrawn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
BladderScan BVI 6x00 Calibration Phantom EUDAMED
BladderScan® GUDID
Generic name
Ultrasound system quality assurance device
Device name
Calibration Equipment
Model / Ref / Catalog
0620-0068, Tissue-Equivalent Phantom
Primary DI / UDI-DI
00879123001962
Basic UDI-DI
0879123000015X4
FDA product code
IYO
EMDN code
V0399 Measurement devices - other
GMDN term
Ultrasound system quality assurance device
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0620-0068
GUDID
Tissue-Equivalent Phantom
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: Ultrasound system quality assurance device

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Other devices filed under MEASUREMENT DEVICES - OTHER.

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)