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BladderScan® Prime

by Verathon Inc

Ref 0800-0532

BladderScan Prime (0800-0532) is an electromechanical device/system transport trolley (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 087912300-0010JT), cleared under FDA 510(k) K153101 on 19 Nov 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00879123004598), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153101

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number087912300-0010JT Basic UDI-DI 00879123004598UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123004598 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153101 Date19 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 087912300-0010JT registered 28 Oct 2026 Active
  • FDA 510(k) K153101 decided 19 Nov 2015 Active
  • FDA GUDID UDI-DI 00879123004598 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153101
  2. Listed FDA GUDID 00879123004598
  3. Registered EUDAMED 087912300-0010JT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
BladderScan Prime Cart EUDAMED
BladderScan® GUDID
Generic name
Electromechanical device/system transport trolley
Device name
Workstations, Carts, and Equipment Mounts
Model / Ref / Catalog
0800-0532, Prime
Primary DI / UDI-DI
00879123004598
Basic UDI-DI
087912300-0010JT
510(k) Number
FDA product code
IYO
EMDN code
Z12029003 Endoscope transport carts
GMDN term
Electromechanical device/system transport trolley
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
0800-0532
GUDID
Prime
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: Electromechanical device/system transport trolley

Cleared under the same submission (K153101)

Similar devices in this category

Other devices filed under ENDOSCOPE TRANSPORT CARTS.

Other devices from Verathon Inc

See all devices from Verathon Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)