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Amplivox Otowave 302+

by Amplivox, Ltd.

Ref 8519028

Amplivox Otowave 302+ is a device classified as Class IIa in the EU and Class II in the US made by Amplivox, Ltd., registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 506048890_8519028_G9), cleared under FDA 510(k) K171265 on 28 Jul 2017 and listed in FDA GUDID since 22 Dec 2023 (UDI-DI 05060488902680), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171265

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506048890_8519028_G9 Basic UDI-DI 05060488902680UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060488902680 UDI-DI Date22 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171265 Date28 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506048890_8519028_G9 registered 4 Aug 2026 Active
  • FDA 510(k) K171265 decided 28 Jul 2017 Active
  • FDA GUDID UDI-DI 05060488902680 listed 22 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171265
  2. Listed FDA GUDID 05060488902680
  3. Registered EUDAMED 506048890_8519028_G9

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  • Withdrawn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
Otowave 302+ EUDAMED
Amplivox GUDID
Generic name
Vestibulo-auditory analysis system
Model / reference
8519028 EUDAMED
Otowave 302+ GUDID
Primary DI / UDI-DI
05060488902680
Basic UDI-DI
506048890_8519028_G9
Direct marketing DI
05060488902680
510(k) Number
FDA product code
ETY
EMDN code
Z12149005 Impedance meters for the auditory system
GMDN term
Vestibulo-auditory analysis system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1090
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8519028
GUDID
Otowave 302+
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: Vestibulo-auditory analysis system

Cleared under the same submission (K171265)

Similar devices in this category

Other devices filed under IMPEDANCE METERS FOR THE AUDITORY SYSTEM.

Other devices from Amplivox, Ltd.

See all devices from Amplivox, Ltd. →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)