Identity
- Device Name
- Ear Electrodes EUDAMED
- Model / Reference
- 108-4004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251784907009 EUDAMED
- Basic UDI-DI
- 42517849ELAM EUDAMED
- Direct Marketing DI
- 04251784907009 EUDAMED
- EMDN Code
- Z12062880 NEUROMUSCULAR STIMULATION EQUIPMENT - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Ear Electrodes by Healy GMBH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 42517849ELAM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Healy GmbH
- EUDAMED SRN
- DE-MF-000010762
Sources (1)
- EUDAMED 4ed2b291-8bc6-4786-82a6-2ab7084dffb1 61 fields · synced Oct 9, 2026