Skip to content

Maico ERO SCAN

by MAICO Diagnostics GmbH

Ref 8104863

Maico ERO SCAN 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_8104863_25) and listed in FDA GUDID since 17 Apr 2020 (UDI-DI 04260176120148), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426017612_8104863_25 Basic UDI-DI 04260176120148UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260176120148 UDI-DI Date17 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426017612_8104863_25 registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 04260176120148 listed 17 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260176120148
  2. Registered EUDAMED 426017612_8104863_25

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  • Withdrawn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
Ero Scan EUDAMED
Maico GUDID
Generic name
Otoacoustic emission system, battery-powered
Model / reference
8104863 EUDAMED
ERO SCAN GUDID
Primary DI / UDI-DI
04260176120148
Basic UDI-DI
426017612_8104863_25
Direct marketing DI
04260176120148
FDA product code
EWO
EMDN code
Z12149001 Otoacoustic emissions equipment
GMDN term
Otoacoustic emission system, battery-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
8104863
GUDID
ERO SCAN
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: Otoacoustic emission system, battery-powered

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

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)