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Drum

by Inventis SRL

Ref 11239Model Drum

Drum (11239) 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 805418738HT1LE) and listed in FDA GUDID since 24 Aug 2017 (UDI-DI 08054187380730), 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 Number805418738HT1LE Basic UDI-DI 08054187380730UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380730 UDI-DI Date24 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738HT1LE registered 10 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187380730 listed 24 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380730
  2. Registered EUDAMED 805418738HT1LE

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  • Withdrawn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
Hearing aid tester, electrical
Model / Ref / Catalog
DRUM, 11239
Primary DI / UDI-DI
08054187380730
Basic UDI-DI
805418738HT1LE
FDA product code
ETW
EMDN code
Z12149099 Various ENT instruments - other
GMDN term
Hearing aid tester, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3310
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: Hearing aid tester, electrical

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - OTHER.

Other devices from Inventis SRL

See all devices from Inventis SRL →

Properties

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