Identity
- Trade Name
- Viola Basic with printer EUDAMEDVIOLA FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- Viola EUDAMEDMIDDLE EAR ANALYZER / AUDIOMETER. Viola Basic is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically; pure tone audiometry using air and bone conduction. Viola Basic with Printer has, in addition, an integrated thermal printer. FDA UDI
- Model / Reference
- Viola EUDAMED10344 EUDAMEDVIOLA BASIC WITH PRINTER FDA UDI
- Description
- MIDDLE EAR ANALYZER / AUDIOMETER. Viola Basic is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically; pure tone audiometry using air and bone conduction. Viola Basic with Printer has, in addition, an integrated thermal printer. FDA UDI
Identifiers
- Catalog Number
- 10344 FDA UDI
- Primary DI / UDI-DI
- 08054187380419 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738IM1DVBC EUDAMED
- FDA Product Code
- PTO FDA UDI
- EMDN Code
- Z121401,Z12149005 EUDAMED
- GMDN Term
- Impedance 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
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- 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 a9cd3dc3-8ce4-42ea-9d56-551dc27e1a5c 35 fields · synced Jul 13, 2026
- EUDAMED 6c40169c-6697-4172-86b5-95bf6d17f844 61 fields · synced Jul 13, 2026