Phonak Brand
FDA UDIEUDAMEDClass I (US FDA UDI)
by Sonova AG
Identity
- Trade Name
- Lyric Programming Wand EUDAMEDPhonak Brand FDA UDI
- Generic Name
- Hearing aid wireless-fitting computer-aided set FDA UDI
- Device Name
- Sonova in ear hearing solution assistant tools EUDAMEDLyric programming wand FDA UDI
- Model / Reference
- 058-0151 EUDAMEDFDA UDISonova in ear hearing solution assistant tools EUDAMED
- Description
- Lyric programming wand FDA UDI
Identifiers
- Catalog Number
- 058-0151 FDA UDI
- Primary DI / UDI-DI
- 07613389392746 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389IAHSATH8 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid wireless-fitting computer-aided set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Hearing aid wireless-fitting computer-aided set
Phonak Brand by Sonova AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid wireless-fitting computer-aided set.
- Philips — Sbo Hearing A/S · Class II
- Sonic — Sonic Innovations, Inc. · Class II
- HHM — Sbo Hearing A/S · Class II
- Bernafon — Bernafon, Inc. · Class II
- Bernafon — Bernafon, Inc. · Class II
- Oticon — Sbo Hearing A/S · Class II
- Maico — Sbo Hearing A/S · Class II
- Bernafon — Bernafon, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
Sources (2)
- FDA UDI 607ca6bc-f218-4456-95ef-58b3c24d5e0a 35 fields · synced Jul 9, 2026
- EUDAMED 625518fb-baaa-4068-8545-c65c3e158ece 61 fields · synced Jul 9, 2026