ampli-mini E 4 5P R-R AI PH
FDA UDIEUDAMEDClass II (US FDA UDI)
by Sonova AG
Identity
- Trade Name
- ampli-mini E 4 5P R-R AI PH (sand beige) EUDAMEDampli-mini E 4 5P R-R AI PH FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- Sonova RIC hearing aids EUDAMED
- Model / Reference
- Sonova RIC hearing aids EUDAMED050-1060-P167 EUDAMED(sand beige) FDA UDI
Identifiers
- Catalog Number
- 050-1060-P167 FDA UDI
- Primary DI / UDI-DI
- 07613389776959 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389RICWJ EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 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: Air-conduction hearing aid, receiver-in-canal
ampli-mini E 4 5P R-R AI PH by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 9abac104-9240-443b-b204-4ed6e0ae0921 33 fields · synced Jul 11, 2026
- EUDAMED 79d0613f-d219-4334-9292-d5b0de0a33b4 61 fields · synced Jul 11, 2026