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Piccolo
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10327Model Piccolo Basic
by Inventis Srl
Identity
- Trade Name
- Piccolo Basic EUDAMEDPICCOLO FDA UDI
- Generic Name
- Tone audiometer, manual FDA UDI
- Device Name
- Piccolo EUDAMEDAUDIOMETER. Piccolo Basic is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction. FDA UDI
- Model / Reference
- PICCOLO BASIC EUDAMEDFDA UDI10327 EUDAMED
- Description
- AUDIOMETER. Piccolo Basic is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction. FDA UDI
Identifiers
- Catalog Number
- 10327 FDA UDI
- Primary DI / UDI-DI
- 08054187380341 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738AU1PE5 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Tone audiometer, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 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
No
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: Tone audiometer, manual
Piccolo by Inventis Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer, manual.
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Fonix — FRYE ELECTRONICS, INC. · Class II
- Earscan 3 — Micro Audiometrics Corp. · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- AMBCO — AMBCO ELECTRONICS · Class II
- Fonix — FRYE ELECTRONICS, INC. · 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 d3df6019-7d72-4d29-9ce0-75f05edef48c 35 fields · synced Jul 26, 2026
- EUDAMED c27b97bb-a8b4-47ed-934a-e1866bc20df5 61 fields · synced Jul 26, 2026