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CUBEscan BioCon-1100

by Mcube Technology Co., Ltd

Ref BioCon-1100

CUBEscan BioCon-1100 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-08809458500115), cleared under FDA 510(k) K201995 on 19 Aug 2020 and listed in FDA GUDID since 9 Apr 2020 (UDI-DI 08809458500115), 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) K201995

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809458500115 Basic UDI-DI 08809458500115UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK201995 Date19 Aug 2020DecidedStatusActive
United StatesGUDID listing GUDID Number08809458500115 UDI-DI Date9 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809458500115 registered 5 Feb 2026 Active
  • FDA 510(k) K201995 decided 19 Aug 2020 Active
  • FDA GUDID UDI-DI 08809458500115 listed 9 Apr 2020 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08809458500115
  2. Cleared FDA 510(k) K201995
  3. Registered EUDAMED B-08809458500115

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CUBEscan
Generic name
Bladder volume ultrasound imaging system
Model / reference
BioCon-1100
Primary DI / UDI-DI
08809458500115
Basic UDI-DI
B-08809458500115
510(k) Number
FDA product code
IYO, ITX
EMDN code
Z12080304 Ultrasonic bladder volume scanners
GMDN term
Bladder volume ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1570
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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.

Related devices

Category: Bladder volume ultrasound imaging system

Cleared under the same submission (K201995)

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)