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Orus
EUDAMEDClass IIa (EU MDR)
Ref 293952Model HI (BTE)Ref 267478Ref 265592Ref 265591Ref 265594Ref 293951Ref 267482Ref 293953Ref 265593Ref 267481
Identity
- Trade Name
- Orus EUDAMED
- Model / Reference
- HI (BTE) EUDAMED293952 EUDAMED267478 EUDAMED265592 EUDAMED265591 EUDAMED265594 EUDAMED293951 EUDAMED267482 EUDAMED293953 EUDAMED265593 EUDAMED267481 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464194162 EUDAMED05714464130597 EUDAMED05714464127665 EUDAMED05714464127658 EUDAMED05714464127689 EUDAMED05714464194155 EUDAMED05714464130634 EUDAMED05714464194179 EUDAMED05714464127672 EUDAMED05714464130627 EUDAMED
- Basic UDI-DI
- 57144640-HI-00053-RB 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
Orus 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-00053-RB | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (10)
- EUDAMED a820a90e-d610-479c-be99-d130a13b1e36 61 fields · synced Sep 17, 2026
- EUDAMED 0440e6aa-142d-4069-973d-e2b2fc29b269 61 fields · synced May 17, 2026
- EUDAMED 608bdfcd-64f8-4c31-9ba0-335822d19abc 61 fields · synced May 17, 2026
- EUDAMED 6498820e-42f5-43c5-8bce-13d72792bf15 61 fields · synced May 17, 2026
- EUDAMED 55649afa-0052-4452-ab2f-c1ef00c11286 61 fields · synced May 17, 2026
- EUDAMED b067a6dd-4c48-4533-b577-bd1ce3e55c02 61 fields · synced May 18, 2026
- EUDAMED abba4223-af21-4942-a7ec-4c1f9ad72cbf 61 fields · synced May 18, 2026
- EUDAMED d01abea6-b1e9-4d8e-8c89-942331f2d518 61 fields · synced May 18, 2026
- EUDAMED 23de2240-5557-4863-82fb-ed240d461358 61 fields · synced May 18, 2026
- EUDAMED dcae26f2-a280-4cfc-af46-a386ff278003 61 fields · synced May 19, 2026