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Maico MB 11 BERAphone

by MAICO Diagnostics GmbH

Ref 8525704

Maico MB 11 BERAphone is a device classified as Class IIa in the EU and Class II in the US made by MAICO Diagnostics GmbH, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 426017612_8525704_4C), cleared under FDA 510(k) K082035 on 29 Jan 2009 and listed in FDA GUDID since 17 Apr 2020 (UDI-DI 04260176120513), 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) K082035

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 Number426017612_8525704_4C Basic UDI-DI 04260176120513UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176120513 UDI-DI Date17 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082035 Date29 Jan 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8525704_4C registered 2 Oct 2026 Active
  • FDA 510(k) K082035 decided 29 Jan 2009 Active
  • FDA GUDID UDI-DI 04260176120513 listed 17 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082035
  2. Listed FDA GUDID 04260176120513
  3. Registered EUDAMED 426017612_8525704_4C

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  • Withdrawn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
MB 11 BERAphone EUDAMED
Maico GUDID
Generic name
Evoked-potential audiometer
Model / reference
8525704 EUDAMED
MB 11 BERAphone GUDID
Primary DI / UDI-DI
04260176120513
Basic UDI-DI
426017612_8525704_4C
Direct marketing DI
04260176120513
510(k) Number
FDA product code
GWJ
EMDN code
Z12140302 Evoked potential audiometry equipments
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1900
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8525704
GUDID
MB 11 BERAphone
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: Evoked-potential audiometer

Cleared under the same submission (K082035)

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS.

Other devices from Maico Diagnostic GmbH

See all devices from Maico Diagnostic GmbH →

Properties

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