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Maico DE touchTymp

by MAICO Diagnostics GmbH

Ref 8537339

Maico DE touchTymp 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_8537339_5H) and listed in FDA GUDID since 23 Dec 2016 (UDI-DI 04260176121046), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

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_8537339_5H Basic UDI-DI 04260176121046UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176121046 UDI-DI Date23 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8537339_5H registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 04260176121046 listed 23 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260176121046
  2. Registered EUDAMED 426017612_8537339_5H

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
touchTymp EUDAMED
Maico DE GUDID
Generic name
Impedance audiometer
Model / reference
8537339 EUDAMED
touchTymp GUDID
Primary DI / UDI-DI
04260176121046
Basic UDI-DI
426017612_8537339_5H
Direct marketing DI
04260176121046
FDA product code
ETY
EMDN code
Z121401, Z12149005
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
8537339
GUDID
touchTymp
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)