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Piccolo Speech

by Inventis SRL

Part of a family of 6 devices: see the family page

Ref 10331Model Piccolo

Piccolo Speech (10331) is a device classified as Class IIa in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 805418738AU1PE5) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 08054187380389), 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 Number805418738AU1PE5 Basic UDI-DI 08054187380389UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380389 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738AU1PE5 registered 11 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187380389 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380389
  2. Registered EUDAMED 805418738AU1PE5

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  • Withdrawn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
Piccolo Speech EUDAMED
Piccolo GUDID
Generic name
Tone audiometer
Model / Ref / Catalog
Piccolo, 10331, PICCOLO SPEECH
Primary DI / UDI-DI
08054187380389
Basic UDI-DI
805418738AU1PE5
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
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Piccolo
10331
GUDID
PICCOLO SPEECH
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 Inventis SRL

See all devices from Inventis SRL →

Properties

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