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Lisound
EUDAMEDClass IIa (EU MDR)
Ref 237841Model HI (BTE)Ref 237844Ref 229555Ref 228598Ref 228597Ref 247909Ref 247911Ref 229554Ref 229558Ref 228596Ref 229557
Identity
- Trade Name
- Lisound EUDAMED
- Model / Reference
- HI (BTE) EUDAMED237841 EUDAMED237844 EUDAMED229555 EUDAMED228598 EUDAMED228597 EUDAMED247909 EUDAMED247911 EUDAMED229554 EUDAMED229558 EUDAMED228596 EUDAMED229557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711584125120 EUDAMED05711584126189 EUDAMED05714464026159 EUDAMED05714464020270 EUDAMED05714464019946 EUDAMED05714464069347 EUDAMED05714464069606 EUDAMED05714464025633 EUDAMED05714464027330 EUDAMED05714464019533 EUDAMED05714464027019 EUDAMED
- Basic UDI-DI
- 57144640-HI-000015-WT EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMEDY2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) 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
Lisound 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-000015-WT | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (11)
- EUDAMED 17b94cfd-945a-4d94-b744-48f926aed68a 61 fields · synced Aug 4, 2026
- EUDAMED c4bd01ec-3a82-42d2-b144-5626045ee168 61 fields · synced May 11, 2026
- EUDAMED 169558c0-d59e-4a11-9b24-527a970592ae 61 fields · synced May 11, 2026
- EUDAMED 5b6dc613-ba2f-4263-a73d-e1b4c91e3649 61 fields · synced May 16, 2026
- EUDAMED 32989232-9868-4263-af7f-8abb90135d36 61 fields · synced May 16, 2026
- EUDAMED 26ce8c3f-3a65-4bad-9c73-345c4b238c7a 61 fields · synced May 17, 2026
- EUDAMED 2d781ee9-cc2e-49e2-8cad-b9fb58e19b0d 61 fields · synced May 17, 2026
- EUDAMED 055e0278-9f02-4e87-8a49-0abf82b376ce 61 fields · synced May 17, 2026
- EUDAMED 469cb7eb-3737-4057-a2e9-501f898c9b6c 61 fields · synced May 17, 2026
- EUDAMED 069b00f7-abd9-4ef0-a55e-24f00d0c0898 61 fields · synced May 18, 2026
- EUDAMED 678dacf3-7590-4be8-8121-8c0f2aaf8774 61 fields · synced May 18, 2026