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Maico MA 28

by MAICO Diagnostics GmbH

Ref 8502545

Maico MA 28 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 20 Aug 2026 (Basic UDI-DI 426017612_8502545_2S) and listed in FDA GUDID since 27 Jul 2017 (UDI-DI 04260176121114), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426017612_8502545_2S Basic UDI-DI 04260176121114UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176121114 UDI-DI Date27 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8502545_2S registered 20 Aug 2026 Active
  • FDA GUDID UDI-DI 04260176121114 listed 27 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260176121114
  2. Registered EUDAMED 426017612_8502545_2S

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  • Withdrawn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
Ma 28 EUDAMED
Maico GUDID
Generic name
Tone audiometer
Model / reference
8502545 EUDAMED
MA 28 GUDID
Primary DI / UDI-DI
04260176121114
Basic UDI-DI
426017612_8502545_2S
Direct marketing DI
04260176121114
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Tone audiometer
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
8502545
GUDID
MA 28
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: Tone audiometer

Similar devices in this category

Other devices filed under AUDIOMETERS.

Other devices from Maico Diagnostic GmbH

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)