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CUBEScan

by Mcube Technology Co., Ltd 4 variants

Ref BioCon-700

CUBEScan (BioCon-700) is a device classified as Class IIa in the EU and Class II in the US made by Mcube Technology Co., Ltd, registered in EUDAMED on 5 Feb 2026 (Basic UDI-DI B-08809458500016), cleared under FDA 510(k) K111021 on 27 Apr 2011 and listed in FDA GUDID since 23 Apr 2015 (UDI-DI 08809458500016), active as of 25 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111021↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809458500016 Basic UDI-DI 08809458500016UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809458500016 UDI-DI Date23 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK111021 Date27 Apr 2011IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809458500016 registered 5 Feb 2026 Active
  • FDA 510(k) K111021 decided 27 Apr 2011 Active
  • FDA GUDID UDI-DI 08809458500016 listed 23 Apr 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111021
  2. Listed FDA GUDID 08809458500016
  3. Registered EUDAMED B-08809458500016

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Bladder volume ultrasound imaging system
Device name
Bladder Volume Measurement System
Model / reference
BioCon-700
Primary DI / UDI-DI
08809458500016
Basic UDI-DI
B-08809458500016
FDA product code
ITX, IYO
EMDN code
Z12080304 Ultrasonic bladder volume scanners
GMDN term
Bladder volume ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1560
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000020590
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under ULTRASONIC BLADDER VOLUME SCANNERS.

Other devices from Mcube Technology Co., Ltd

See all devices from Mcube Technology Co., Ltd →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)