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Amplivox Otowave 102

by Amplivox, Ltd.

Ref 8000402

Amplivox Otowave 102 is a device classified as Class IIa in the EU and Class II in the US made by Amplivox, Ltd., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 506048890_8000402_A4), cleared under FDA 510(k) K081841 on 16 Jul 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05060488901010), 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) K081841

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 Number506048890_8000402_A4 Basic UDI-DI 05060488901010UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060488901010 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081841 Date16 Jul 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506048890_8000402_A4 registered 3 Aug 2026 Active
  • FDA 510(k) K081841 decided 16 Jul 2008 Active
  • FDA GUDID UDI-DI 05060488901010 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081841
  2. Listed FDA GUDID 05060488901010
  3. Registered EUDAMED 506048890_8000402_A4

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  • Withdrawn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 102 EUDAMED
Amplivox GUDID
Generic name
Impedance audiometer
Model / reference
8000402 EUDAMED
Otowave 102 GUDID
Primary DI / UDI-DI
05060488901010
Basic UDI-DI
506048890_8000402_A4
Direct marketing DI
05060488901010
510(k) Number
FDA product code
ETY
EMDN code
Z12149005 Impedance meters for the auditory system
GMDN term
Impedance audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1090
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8000402
GUDID
Otowave 102
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: Impedance audiometer

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)