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VivoTab Electrode (4 pack) 100001

by Vivosonic Inc

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

Ref 100001Model Integrity™ V500

VivoTab Electrode (4 pack) 100001 is a device classified as Class IIa and Class I 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 29 Oct 2019 (UDI-DI 00627908070067), 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 Number62790802049R Basic UDI-DI 00627908070067UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00627908070067 UDI-DI Date29 Oct 2019ListedStatusListed 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 00627908070067 listed 29 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K043396
  2. Listed FDA GUDID 00627908070067
  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  • Withdrawn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
VivoTab™ Electrode EUDAMED
VivoTab Electrode (4 pack) GUDID
Generic name
Evoked-potential audiometer
Device name
Integrity™ V500
Integrity V500 Patient-Connection Accessories
Model / reference
100001, Integrity™ V500
Primary DI / UDI-DI
00627908070067
Basic UDI-DI
62790802049R, 62790802069V
510(k) Number
FDA product code
GWJ
EMDN code
Z12140392, N01010202
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation number
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
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa and Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Evoked-potential audiometer

Cleared under the same submission (K043396)

and 8 more cleared under K043396

Similar devices in this category

Other devices filed under EEG EXTRACRANIC ELECTRODES.

Other devices from Vivosonic Inc

See all devices from Vivosonic Inc →

Properties

  • Single use
  • Measuring function YesEUDAMEDNoEUDAMED
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)