Identity
- Trade Name
- AUDIOSMART EUDAMED
- Device Name
- ELIOS EUDAMED
- Model / Reference
- ECH001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701330200395 EUDAMED
- Basic UDI-DI
- 137013302ECH001KP1XXKH EUDAMED
- EMDN Code
- V030208 ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Audiosmart by Electronique Du Mazet — Class IIa — 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 | 137013302ECH001KP1XXKH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Electronique Du Mazet
- EUDAMED SRN
- FR-MF-000001805
Sources (1)
- EUDAMED 914e2c35-2a41-41bd-9f02-befd7b3b3538 61 fields · synced Aug 4, 2026