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Maico easyTymp

by MAICO Diagnostics GmbH

Ref 8514964

Maico easyTymp 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on 2 Oct 2026 (Basic UDI-DI 426017612_8514964_4Y) and listed in FDA GUDID since 17 Apr 2020 (UDI-DI 04260176120834), withdrawn as of 24 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426017612_8514964_4Y Basic UDI-DI 04260176120834UDI-DIDate2 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04260176120834 UDI-DI Date17 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8514964_4Y registered 2 Oct 2026 Withdrawn
  • FDA GUDID UDI-DI 04260176120834 listed 17 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260176120834
  2. Registered EUDAMED 426017612_8514964_4Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
easyTymp EUDAMED
Maico GUDID
Generic name
Impedance audiometer
Model / reference
8514964 EUDAMED
easyTymp GUDID
Primary DI / UDI-DI
04260176120834
Basic UDI-DI
426017612_8514964_4Y
Direct marketing DI
04260176120834
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8514964
GUDID
easyTymp
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 Maico Diagnostic GmbH

See all devices from Maico Diagnostic GmbH →

Properties

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