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Maico DE easyScreen

by MAICO Diagnostics GmbH

Ref 8108399

Maico DE easyScreen 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_8108399_3F), cleared under FDA 510(k) K171506 on 29 Aug 2017 and listed in FDA GUDID since 30 Jan 2018 (UDI-DI 04260176121169), 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) K171506

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_8108399_3F Basic UDI-DI 04260176121169UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176121169 UDI-DI Date30 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171506 Date29 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8108399_3F registered 2 Oct 2026 Active
  • FDA 510(k) K171506 decided 29 Aug 2017 Active
  • FDA GUDID UDI-DI 04260176121169 listed 30 Jan 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171506
  2. Listed FDA GUDID 04260176121169
  3. Registered EUDAMED 426017612_8108399_3F

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  • Withdrawn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
easyScreen EUDAMED
Maico DE GUDID
Generic name
Otoacoustic emission system, line-powered
Model / reference
8108399 EUDAMED
easyScreen GUDID
Primary DI / UDI-DI
04260176121169
Basic UDI-DI
426017612_8108399_3F
Direct marketing DI
04260176121169
510(k) Number
FDA product code
EWO
EMDN code
Z12140302, Z12149001
GMDN term
Otoacoustic emission system, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
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
8108399
GUDID
easyScreen
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 audiometerOtoacoustic emission system, line-powered

Cleared under the same submission (K171506)

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)