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Audika France
EUDAMEDClass IIa (EU MDR)
Ref 221972Model HI (BTE)Ref 221982Ref 221983Ref 221975Ref 221969Ref 221981Ref 221973Ref 221974
Identity
- Trade Name
- Audika France EUDAMED
- Model / Reference
- HI (BTE) EUDAMED221972 EUDAMED221982 EUDAMED221983 EUDAMED221975 EUDAMED221969 EUDAMED221981 EUDAMED221973 EUDAMED221974 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464007516 EUDAMED05714464008674 EUDAMED05714464008681 EUDAMED05714464008070 EUDAMED05714464007486 EUDAMED05714464008667 EUDAMED05714464007523 EUDAMED05714464008063 EUDAMED
- Basic UDI-DI
- 57144640-HI-00052-R8 EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Air-conduction hearing aid, receiver-in-canal
Audika France by Sbo Hearing A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00052-R8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (8)
- EUDAMED f4601312-3c4e-4c69-a625-f05958dee805 61 fields · synced Aug 3, 2026
- EUDAMED 93dbe16f-1c28-443f-a450-2c7f2b5d916d 61 fields · synced May 16, 2026
- EUDAMED 7144c563-2dbc-4d70-ad1a-e156b07e13f6 61 fields · synced May 17, 2026
- EUDAMED 429ebe09-7bf4-4a60-b3e6-80887d687a0e 61 fields · synced May 18, 2026
- EUDAMED 75e8c8be-3054-40a3-aa98-477fcf354384 61 fields · synced May 18, 2026
- EUDAMED f0443234-8faf-40bf-894b-59749930dde1 61 fields · synced May 18, 2026
- EUDAMED 62f3afec-9b6d-4e6c-bbf6-e617d24ec37a 61 fields · synced May 18, 2026
- EUDAMED 4cb23c1e-649a-4d55-8e9b-ef22883791c4 61 fields · synced May 19, 2026