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Integrity Software SWA001

by Vivosonic Inc

Part of a family of 21 devices: see the family page

Ref SWA001Model Integrity™ V500

Integrity Software SWA001 is a device classified as Class IIa in the EU and Class II in the US made by Vivosonic Inc, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 62790802049R), cleared under FDA 510(k) K043396 on 24 Jan 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00627908090010), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K043396

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62790802049R Basic UDI-DI 00627908090010UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00627908090010 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK043396 Date24 Jan 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 62790802049R registered 15 Sep 2026 Active
  • FDA 510(k) K043396 decided 24 Jan 2005 Active
  • FDA GUDID UDI-DI 00627908090010 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K043396
  2. Listed FDA GUDID 00627908090010
  3. Registered EUDAMED 62790802049R

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  • Withdrawn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
SWA001 - Integrity™ Software EUDAMED
Integrity Software GUDID
Generic name
Otoacoustic emission system, battery-powered
Model / reference
SWA001, Integrity™ V500
Primary DI / UDI-DI
00627908090010
Basic UDI-DI
62790802049R
510(k) Number
FDA product code
EWO, GWJ
EMDN code
Z12140392 Evoked potential audiometry instruments - medical device software
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900
System or procedure pack
System which is a device in itself
EU registration type
Standard device
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: Evoked-potential audiometerOtoacoustic emission system, battery-powered

Cleared under the same submission (K043396)

and 8 more cleared under K043396

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS.

Other devices from Vivosonic Inc

See all devices from Vivosonic Inc →

Properties

  • Measuring function
Other properties (24, all answered No)