Identity
- Trade Name
- Viola Plus EUDAMEDVIOLA FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Viola EUDAMEDMIDDLE EAR ANALYZER / AUDIOMETER. Viola Plus is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically, reflex test decay; pure tone and speech audiometry using air and bone conduction. FDA UDI
- Model / Reference
- Viola EUDAMED10374 EUDAMEDVIOLA PLUS FDA UDI
- Description
- MIDDLE EAR ANALYZER / AUDIOMETER. Viola Plus is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically, reflex test decay; pure tone and speech audiometry using air and bone conduction. FDA UDI
Identifiers
- Catalog Number
- 10374 FDA UDI
- Primary DI / UDI-DI
- 08054187380426 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738IM1DVBC EUDAMED
- FDA Product Code
- PTO FDA UDI
- EMDN Code
- Z121401,Z12149005 EUDAMED
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Impedance audiometerTone audiometer
Viola by Inventis Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
- TREMETRICS — MAICO Diagnostics GmbH · Class II
- SHOEBOX AUDIOMETRY — SHOEBOX Ltd · Class II
- nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake — PATH medical GmbH · Class II
- Otometrics — Natus Medical Denmark ApS · Class II
- Benson — MAICO Diagnostics GmbH · Class II
- Maico — MAICO Diagnostics GmbH · Class II
- nanoAudio DD45 Set with Patient Response Button — PATH medical GmbH · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inventis Srl
Sources (2)
- FDA UDI c3ab5867-a7f9-412a-a2f1-afc9db539e3c 35 fields · synced Jun 19, 2026
- EUDAMED 8b9d23fb-e497-4226-a195-29cd10f60704 61 fields · synced Jun 19, 2026