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Viola Plus with Printer

by Inventis SRL

Ref 10375Model Viola

Viola Plus with Printer (10375) is a device classified as Class IIa in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI 805418738IM1DVBC) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 08054187380433), 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 Number805418738IM1DVBC Basic UDI-DI 08054187380433UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380433 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738IM1DVBC registered 9 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187380433 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380433
  2. Registered EUDAMED 805418738IM1DVBC

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  • Withdrawn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
Viola Plus with printer EUDAMED
Viola GUDID
Generic name
Impedance audiometer
Model / Ref / Catalog
Viola, 10375, VIOLA PLUS WITH PRINTER
Primary DI / UDI-DI
08054187380433
Basic UDI-DI
805418738IM1DVBC
FDA product code
PTO
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
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Viola
10375
GUDID
VIOLA PLUS WITH PRINTER
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 audiometerTone audiometer

Similar devices in this category

Other devices filed under IMPEDANCE METERS FOR THE AUDITORY SYSTEM.

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Properties

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