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Timpani Docking Station

by Inventis SRL

Ref 11508Model Timpani-Docking Station

Timpani Docking Station (11508) is a device classified as Class I in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 805418738IM1PBB8) and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 08054187380761), active as of 21 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 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805418738IM1PBB8 Basic UDI-DI 08054187380761UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380761 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738IM1PBB8 registered 10 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187380761 listed 4 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380761
  2. Registered EUDAMED 805418738IM1PBB8

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  • Withdrawn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
Impedance audiometer
Model / Ref / Catalog
Timpani-Docking Station, 11508, TIMPANI DOCKING STATION
Primary DI / UDI-DI
08054187380761
Basic UDI-DI
805418738IM1PBB8
FDA product code
PTO, EWO
EMDN code
Z12149080 Various ENT instruments - hardware accessories
GMDN term
Impedance audiometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1090, 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
Timpani-Docking Station
11508
GUDID
TIMPANI DOCKING STATION
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: Impedance audiometerTone audiometer

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

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