Identity
- Trade Name
- FLUTE FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. FDA UDI
- Model / Reference
- FLUTE HF FDA UDI
- Description
- MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. FDA UDI
Identifiers
- Catalog Number
- 10409 FDA UDI
- Primary DI / UDI-DI
- 08054187380440 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 69309089-e156-47fb-a440-fbc882a6c3d1 35 fields · synced May 30, 2026