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EasyView Otoblock M

by Sonova AG

Part of a family of 7 devices: see the family page

Ref 054-0768Model Sonova in ear hearing solution assistant tools

EasyView Otoblock M (054-0768) is a Class I device made by Sonova AG, registered in EUDAMED on 5 Sep 2023 (Basic UDI-DI 07613389IAHSATH8) and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 07613275561584), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613389IAHSATH8 Basic UDI-DI 07613275561584UDI-DIDate5 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07613275561584 UDI-DI Date1 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 07613389IAHSATH8 registered 5 Sep 2023 Active
  • FDA GUDID UDI-DI 07613275561584 listed 1 Nov 2021 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 07613275561584
  2. Registered EUDAMED 07613389IAHSATH8

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  • Withdrawn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
EasyView Otoblock M EUDAMED
Phonak Brand GUDID
Generic name
Earmould impression kit
Device name
Sonova in ear hearing solution assistant tools
Model / Ref / Catalog
Sonova in ear hearing solution assistant tools, 054-0768
Primary DI / UDI-DI
07613275561584
Basic UDI-DI
07613389IAHSATH8
FDA product code
ESD
EMDN code
Y214580 Hearing aids or hearing devices - accessories
GMDN term
Earmould impression kit
Device class
Class I
Regulation number
874.3300
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Manufacturer details

EUDAMED SRN
CH-MF-000015958
Authorised representative
Sonova Deutschland GmbH DE-AR-000006322

Similar devices in this category

Other devices filed under HEARING AIDS OR HEARING DEVICES - ACCESSORIES.

Other devices from Sonova AG

See all devices from Sonova AG →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)