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Clarinet
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10517Model Clarinet
by Inventis Srl
Identity
- Trade Name
- Clarinet Basic EUDAMEDCLARINET FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- Clarinet EUDAMEDMIDDLE EAR ANALYZER. Clarinet Basic is a clinical middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, acoustic reflex decay, acoustic reflex latency, Eustachian Tube Function (ETF) both for intact and perforated tympanic membrane. FDA UDI
- Model / Reference
- Clarinet EUDAMED10517 EUDAMEDCLARINET BASIC FDA UDI
- Description
- MIDDLE EAR ANALYZER. Clarinet Basic is a clinical middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, acoustic reflex decay, acoustic reflex latency, Eustachian Tube Function (ETF) both for intact and perforated tympanic membrane. FDA UDI
Identifiers
- Catalog Number
- 10517 FDA UDI
- Primary DI / UDI-DI
- 08054187380464 EUDAMEDFDA UDI
- Basic UDI-DI
- 805418738IM1CDT 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
Clarinet 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 54560099-30df-42ae-a502-24eb66a0f743 35 fields · synced Sep 18, 2026
- EUDAMED adef5dd1-ede2-4104-b1e4-8391c5cad51b 61 fields · synced Sep 18, 2026