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idis
EUDAMEDClass IIa (EU MDR)
Ref 221920Model HI (BTE)Ref 230415Ref 230414Ref 230413Ref 221921
Identity
- Trade Name
- idis EUDAMED
- Model / Reference
- HI (BTE) EUDAMED221920 EUDAMED230415 EUDAMED230414 EUDAMED230413 EUDAMED221921 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464007905 EUDAMED05714464030682 EUDAMED05714464030125 EUDAMED05714464029563 EUDAMED05714464008483 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
idis 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 (5)
- EUDAMED a0861d56-a5f1-49b2-997d-a3b7abe7cdbb 61 fields · synced Jul 25, 2026
- EUDAMED 5db81c3e-0eaa-4dd3-850e-bd3345418629 61 fields · synced May 17, 2026
- EUDAMED 641c9624-c464-426b-b5d1-c7495d94a825 61 fields · synced May 17, 2026
- EUDAMED 1e33f339-163d-4538-8ad2-78946d20c281 61 fields · synced May 17, 2026
- EUDAMED ca9a8789-6803-40f5-a1a5-a51392f12e44 61 fields · synced May 18, 2026