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easyTymp

by INVENTIS S.r.l.

Ref 12467Model easyTymp

easyTymp (12467) is a device classified as Class IIa in the EU and Class II in the US made by INVENTIS S.r.l., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 805418738IM1PMBW) and listed in FDA GUDID since 23 Apr 2026 (UDI-DI 08054187381232), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805418738IM1PMBW Basic UDI-DI 08054187381232UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08054187381232 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805418738IM1PMBW registered 10 Jun 2026 Active
  • FDA GUDID UDI-DI 08054187381232 listed 23 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08054187381232
  2. Registered EUDAMED 805418738IM1PMBW

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  • Withdrawn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
easyTymp, 12467
Primary DI / UDI-DI
08054187381232
Basic UDI-DI
805418738IM1PMBW
FDA product code
PTO
EMDN code
Z12149005 Impedance meters for the auditory system
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
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
IT-MF-000012495

Related devices

Category: Impedance audiometer

Similar devices in this category

Other devices filed under IMPEDANCE METERS FOR THE AUDITORY SYSTEM.

Other devices from INVENTIS S.r.l.

See all devices from INVENTIS S.r.l. →

Properties

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