Trumpet
FDA UDIEUDAMEDClass II (US FDA UDI)
by Inventis Srl
Identity
- Trade Name
- Trumpet REM EUDAMEDTRUMPET FDA UDI
- Generic Name
- Ear canal insertion gain measurement instrument FDA UDI
- Device Name
- Trumpet EUDAMEDTrumpet REM is a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process. FDA UDI
- Model / Reference
- Trumpet EUDAMED10866 EUDAMEDTRUMPET REM FDA UDI
- Description
- Trumpet REM is a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process. FDA UDI
Identifiers
- Catalog Number
- 10866 FDA UDI
- Primary DI / UDI-DI
- 08054187380556 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738RE1LK EUDAMED
- FDA Product Code
- ETW FDA UDI
- EMDN Code
- Z121401,Z12149099 EUDAMED
- GMDN Term
- Ear canal insertion gain measurement instrument FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Ear canal insertion gain measurement instrument
Trumpet by Inventis Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ear canal insertion gain measurement instrument.
- TRUMPET — INVENTIS SRL · Class II
- TRUMPET — INVENTIS SRL · Class II
- TRUMPET — INVENTIS SRL · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inventis Srl
Sources (2)
- FDA UDI da99f010-adda-4d0c-90a8-b876d4d6602e 35 fields · synced Jun 18, 2026
- EUDAMED 3b007c2e-c326-4d78-aae9-4f58ecbe98bd 61 fields · synced Jun 18, 2026