Identity
- Trade Name
- PIANO FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- AUDIOMETER. Piano Plus is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry, Bekesy and MLD tests. Piano Plus with Printer has, in addition, an integrated thermal printer. FDA UDI
- Model / Reference
- PIANO PLUS WITH PRINTER FDA UDI
- Description
- AUDIOMETER. Piano Plus is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry, Bekesy and MLD tests. Piano Plus with Printer has, in addition, an integrated thermal printer. FDA UDI
Identifiers
- Catalog Number
- 10165 FDA UDI
- Primary DI / UDI-DI
- 08054187380112 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Tone audiometer
Piano by Inventis Srl — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inventis Srl
Sources (1)
- FDA UDI eac0d88c-59cb-4c04-9a36-2ba7f3f90bba 35 fields · synced Jun 6, 2026