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Tablet Computer for OtoNova Pro NOVA-TABLET

by Otodynamics

Ref NOVA-TABLETModel PC

Tablet Computer for OtoNova Pro NOVA-TABLET is an otoacoustic emission system (EU MDR Class I; FDA Class II) made by Otodynamics, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 506039617PCR2), cleared under FDA 510(k) K234095 on 21 Jun 2024 and listed in FDA GUDID since 20 Aug 2024 (UDI-DI 05060396171512), 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) K234095

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 Number506039617PCR2 Basic UDI-DI 05060396171512UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060396171512 UDI-DI Date20 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK234095 Date21 Jun 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506039617PCR2 registered 3 Nov 2026 Active
  • FDA 510(k) K234095 decided 21 Jun 2024 Active
  • FDA GUDID UDI-DI 05060396171512 listed 20 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K234095
  2. Listed FDA GUDID 05060396171512
  3. Registered EUDAMED 506039617PCR2

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  • Withdrawn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
OtoNova Tablet-PC EUDAMED
Tablet Computer for OtoNova Pro GUDID
Generic name
Otoacoustic emission system, battery-powered
Device name
Otodynamics Tablet, Laptop/PC
Model / reference
NOVA-TABLET, PC
Primary DI / UDI-DI
05060396171512
Basic UDI-DI
506039617PCR2
Direct marketing DI
05060396171512
510(k) Number
FDA product code
EWO, GWJ
EMDN code
Z12149001 Otoacoustic emissions equipment
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
Spain
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 (K234095)

and 8 more cleared under K234095

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

Other devices from Otodynamics

See all devices from Otodynamics →

Properties

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