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Maico MB11 Classic

by MAICO Diagnostics GmbH

Ref 8511545

Maico MB11 Classic 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_8511545_2U), cleared under FDA 510(k) K082035 on 29 Jan 2009 and listed in FDA GUDID since 17 Apr 2020 (UDI-DI 04260176120520), 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_8511545_2U Basic UDI-DI 04260176120520UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176120520 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_8511545_2U registered 2 Oct 2026 Active
  • FDA 510(k) K082035 decided 29 Jan 2009 Active
  • FDA GUDID UDI-DI 04260176120520 listed 17 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082035
  2. Listed FDA GUDID 04260176120520
  3. Registered EUDAMED 426017612_8511545_2U

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  • Withdrawn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 Classic EUDAMED
Maico GUDID
Generic name
Evoked-potential audiometer
Model / reference
8511545 EUDAMED
MB11 Classic GUDID
Primary DI / UDI-DI
04260176120520
Basic UDI-DI
426017612_8511545_2U
Direct marketing DI
04260176120520
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
8511545
GUDID
MB11 Classic
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)