Identity
- Trade Name
- TIMPANI FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- MIDDLE EAR ANALYZER / AUDIOMETER. Timpani is a portable middle ear analyzer / audiometer, capable of performing tympanometry. With additional licenses, it can perform acoustic ipsi-reflex tests in sequence and automatically and pure tone audiometry using air conduction. FDA UDI
- Model / Reference
- TIMPANI FDA UDI
- Description
- MIDDLE EAR ANALYZER / AUDIOMETER. Timpani is a portable middle ear analyzer / audiometer, capable of performing tympanometry. With additional licenses, it can perform acoustic ipsi-reflex tests in sequence and automatically and pure tone audiometry using air conduction. FDA UDI
Identifiers
- Catalog Number
- 11440 FDA UDI
- Primary DI / UDI-DI
- 08054187380747 FDA UDI
- FDA Product Code
- PTO FDA UDIEWO FDA UDI
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI874.1050 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: Impedance audiometerTone audiometer
Timpani by Inventis Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 8d1812cc-e201-4851-87a7-f623d4647d14 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026