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Maestro Control Panel

by Inventis SRL

Ref 12080Model Maestro Control Panel

Maestro Control Panel (12080) is a device classified as Class I in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 805418738MA1KDB) and listed in FDA GUDID since 16 Dec 2022 (UDI-DI 08054187380914), active as of 9 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 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805418738MA1KDB Basic UDI-DI 08054187380914UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380914 UDI-DI Date16 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738MA1KDB registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187380914 listed 16 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380914
  2. Registered EUDAMED 805418738MA1KDB

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  • Withdrawn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

Generic name
Tone audiometer
Model / Ref / Catalog
MAESTRO CONTROL PANEL, 12080
Primary DI / UDI-DI
08054187380914
Basic UDI-DI
805418738MA1KDB
FDA product code
EWO
EMDN code
Z12149080 Various ENT instruments - hardware accessories
GMDN term
Tone audiometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Inventis SRL

See all devices from Inventis SRL →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)