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Integrity Computer M500-C

by Vivosonic Inc

Ref M500-C

Integrity Computer M500-C is a device classified as Class I in the EU and Class II in the US made by Vivosonic Inc, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 62790802079X), cleared under FDA 510(k) K043396 on 24 Jan 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00627908020130), active as of 7 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K043396

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62790802079X Basic UDI-DI 00627908020130UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00627908020130 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 62790802079X registered 4 Nov 2026 Active
  • FDA 510(k) K043396 decided 24 Jan 2005 Active
  • FDA GUDID UDI-DI 00627908020130 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K043396
  2. Listed FDA GUDID 00627908020130
  3. Registered EUDAMED 62790802079X

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  • Withdrawn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
Computer EUDAMED
Integrity Computer GUDID
Generic name
Otoacoustic emission system, battery-powered
Device name
Integrity™ V500 Computer
Model / reference
M500-C
Primary DI / UDI-DI
00627908020130
Basic UDI-DI
62790802079X
510(k) Number
FDA product code
EWO, GWJ
EMDN code
Z12140380 Evoked potential audiometry instruments - hardware accessories
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900
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 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: 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 - HARDWARE ACCESSORIES.

Other devices from Vivosonic Inc

See all devices from Vivosonic Inc →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)