Identity
- Trade Name
- HE-M EUDAMED
- Model / Reference
- Receiver unit EUDAMED021958-002-8430-358 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-021958-002-8430-358LV EUDAMED
- Basic UDI-DI
- B-021958-002-8430-358LV EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Unlock the full potential of your medical device with the HE-M, a Class IIa audifon receiver unit designed for implantable use. Our expert team has carefully designed this device to meet the most stringent regulatory requirements while offering superior performance and reliability.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-021958-002-8430-358LV | Class IIa | Active |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (1)
- EUDAMED 3c5359da-b287-4073-8ea7-c3c644fd9fb8 61 fields · synced Oct 7, 2026