Identity
- Trade Name
- FLUTE FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- MIDDLE EAR ANALYZER. Flute Plus is a middle ear analyzer, capable of performing: tympanometry, and acoustic reflex tests in sequence and automatically, manual tympanometry, the Eustachian tube function test for intact eardrums, the reflex decay test and the facility of conducting the acoustic reflex test in manual mode. In addition, it allows to manually adjust the pressure setting used for reflex tests. FDA UDI
- Model / Reference
- FLUTE PLUS FDA UDI
- Description
- MIDDLE EAR ANALYZER. Flute Plus is a middle ear analyzer, capable of performing: tympanometry, and acoustic reflex tests in sequence and automatically, manual tympanometry, the Eustachian tube function test for intact eardrums, the reflex decay test and the facility of conducting the acoustic reflex test in manual mode. In addition, it allows to manually adjust the pressure setting used for reflex tests. FDA UDI
Identifiers
- Catalog Number
- 10340 FDA UDI
- Primary DI / UDI-DI
- 08054187380273 FDA UDI
- FDA Product Code
- PTO FDA UDI
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 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 audiometer
Flute by Inventis Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Inventis Srl
Sources (1)
- FDA UDI 11e2473f-3ca9-4a2e-bec8-175067f57e6e 35 fields · synced Jun 1, 2026