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Boots Hearingcare 4
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 088-0025-00044Model Sonova hearing aid mobile app
by Sonova AG
Identity
- Trade Name
- Boots Hearingcare 4.4 EUDAMEDBoots Hearingcare 4 FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Sonova hearing aid mobile app EUDAMED
- Model / Reference
- Sonova hearing aid mobile app EUDAMED088-0025-00044 EUDAMED4.2 FDA UDI
Identifiers
- Catalog Number
- 088-0025-00042 FDA UDI
- Primary DI / UDI-DI
- 07613389910186 EUDAMED07613389793949 FDA UDI
- Basic UDI-DI
- 07613389APPSND EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
Boots Hearingcare 4 by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Audiometric/hearing device software.
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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
- Sonova AG
Sources (2)
- FDA UDI 4cc7f13d-7e3b-4772-8ea6-d49083458baf 33 fields · synced Jul 16, 2026
- EUDAMED 76d2db90-74dd-4b5d-8ffa-089b8616829c 61 fields · synced Jul 16, 2026