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Bell Basic

by Inventis SRL

Ref 10143Model Bell

Bell Basic (10143) is a device classified as Class IIa in the EU and Class II in the US made by Inventis SRL, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 805418738AU1DB94) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 08054187380013), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805418738AU1DB94 Basic UDI-DI 08054187380013UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187380013 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738AU1DB94 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 08054187380013 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187380013
  2. Registered EUDAMED 805418738AU1DB94

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  • Withdrawn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
Bell Basic EUDAMED
Bell GUDID
Generic name
Tone audiometer, manual
Model / Ref / Catalog
Bell, 10143, BELL BASIC
Description
AUDIOMETER. Screening audiometer, capable of performing fast and accurate air conduction threshold examination.
Primary DI / UDI-DI
08054187380013
Basic UDI-DI
805418738AU1DB94
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Tone audiometer, manual
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
Bell
10143
GUDID
BELL BASIC
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, manual

Similar devices in this category

Other devices filed under AUDIOMETERS.

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Properties

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