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OtoPad

by Amplifon S.p.A

Ref OTP001Model OtoPad

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08059300420010 UDI-DI Date26 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805930042OTP0019T Basic UDI-DI 08059300420010UDI-DIDate17 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Tone audiometer
Model / Reference
OtoPad EUDAMED
OTP001 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
08059300420010
Basic UDI-DI
805930042OTP0019T
Direct Marketing DI
08059300420010
FDA Product Code
EWO
EMDN Code
Z121401 Audiometers
GMDN Term
Tone audiometer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.1050
Special Device Type
Software
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
OtoPad
OTP001
GUDID
2.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000012109

Other devices from Amplifon S.p.A

See all devices from Amplifon S.p.A →

Properties

  • Measuring Function
  • Premarket Exempt
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No