Identity
- Trade Name
- Flute Basic with printer EUDAMEDFLUTE FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- Flute EUDAMEDMIDDLE EAR ANALYZER. Flute Basic is a screening middle ear analyzer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically. Flute Basic with printer has, in addition, an integrated thermal printer. FDA UDI
- Model / Reference
- Flute EUDAMED10338 EUDAMEDFLUTE BASIC WITH PRINTER FDA UDI
- Description
- MIDDLE EAR ANALYZER. Flute Basic is a screening middle ear analyzer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically. Flute Basic with printer has, in addition, an integrated thermal printer. FDA UDI
Identifiers
- Catalog Number
- 10338 FDA UDI
- Primary DI / UDI-DI
- 08054187380266 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738IM1DFAC EUDAMED
- FDA Product Code
- PTO FDA UDI
- EMDN Code
- Z12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM EUDAMED
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1090 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
Yes
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: Impedance audiometer
Flute 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 dedb7d4b-49fe-4861-9b65-1dd1ab376b5d 35 fields · synced Jul 11, 2026
- EUDAMED 3aadaa75-e8e8-4e2f-a6c4-5f14302f2518 61 fields · synced Jul 11, 2026