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Avantsonic As-1

by Avantsonic Technology Co., Ltd.

Ref Bladder scanner/AS-1Model AS-1

Avantsonic As-1 is a bladder volume ultrasound imaging system (EU MDR Class IIa; FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Avantsonic Technology Co., Ltd., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 697175981000NH), cleared under FDA 510(k) K230986 on 29 Dec 2023 and listed in FDA GUDID since 14 Mar 2024 (UDI-DI 06971759810001), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230986

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697175981000NH Basic UDI-DI 06971759810001UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971759810001 UDI-DI Date14 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230986 Date29 Dec 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697175981000NH registered 27 May 2026 Active
  • FDA 510(k) K230986 decided 29 Dec 2023 Active
  • FDA GUDID UDI-DI 06971759810001 listed 14 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230986
  2. Listed FDA GUDID 06971759810001
  3. Registered EUDAMED 697175981000NH

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  • Withdrawn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
Bladder scanner EUDAMED
Avantsonic GUDID
Generic name
Bladder volume ultrasound imaging system
Model / reference
AS-1, Bladder scanner/AS-1
Primary DI / UDI-DI
06971759810001
Basic UDI-DI
697175981000NH
Direct marketing DI
06971759810001
510(k) Number
FDA product code
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
892.1560
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
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

Similar devices in this category

Other devices filed under ULTRASONIC BLADDER VOLUME SCANNERS.

Other devices from Avantsonic Technology Co., Ltd.

Properties

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