Identity
- Trade Name
- HE-S EUDAMED
- Model / Reference
- Receiver unit EUDAMED021957-220-8431-358 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-021957-220-8431-358NB EUDAMED
- Basic UDI-DI
- B-021957-220-8431-358NB 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
He-S by audifon GmbH & Co. KG — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-021957-220-8431-358NB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (1)
- EUDAMED 4ee782a2-1dcf-46b1-8ccc-4a59e6e5cdad 61 fields · synced Oct 6, 2026