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Phonak
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 054-0847Model Sonova in ear hearing solution assistant tools
by Sonova AG
Identity
- Trade Name
- Titanium FitGuide EUDAMEDPHONAK FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- Sonova in ear hearing solution assistant tools EUDAMEDTitanium FitGuide FDA UDI
- Model / Reference
- 054-0847 EUDAMEDFDA UDISonova in ear hearing solution assistant tools EUDAMED
- Description
- Titanium FitGuide FDA UDI
Identifiers
- Catalog Number
- 054-0847 FDA UDI
- Primary DI / UDI-DI
- 07613389131406 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389IAHSATH8 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing aid tester
Phonak by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing aid tester.
- Audioscan — Etymonic Design Incorporated · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Audioscan — Etymonic Design Incorporated · Class II
- Unity 4 / Measure — Auditdata A/S · Class II
- Unity 4 — Auditdata A/S · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
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
- Sonova AG
Sources (2)
- FDA UDI 48526ed0-becd-4f70-a480-5b3221d16e07 35 fields · synced Jul 31, 2026
- EUDAMED 8496595b-215e-4299-bc6a-7bffd17a44ac 61 fields · synced Jul 31, 2026