Identity
- Trade Name
- HHM EUDAMED
- Model / Reference
- HI (BTE) EUDAMED228811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464015009 EUDAMED
- Basic UDI-DI
- 57144640-HI-000014-WQ EUDAMED
- EMDN Code
- Y2145060101 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
The HHM device is a Class IIa medical device designed for SBO Hearing A/S, which means it has undergone rigorous testing and meets stringent regulatory requirements. With its advanced instrument model HI (BTE) and self-testing capabilities, the HHM offers superior hearing protection for users.
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-000014-WQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (1)
- EUDAMED 45162607-6630-4db3-a610-409251f15936 61 fields · synced Jul 11, 2026