Identity
- Trade Name
- OTODRIVE EUDAMED
- Device Name
- OTODRIVE EUDAMED
- Model / Reference
- 41859 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07616962000014 EUDAMED
- Basic UDI-DI
- 764016722110ODR001VJ EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER 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
Otodrive by CAScination AG — 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 | 764016722110ODR001VJ | Class I | Active |
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Manufacturer
- Manufacturer
- Cascination Ag
- EUDAMED SRN
- CH-MF-000009927
- Authorised Representative
- CAScination Deutschland GmbH DE-AR-000008247
Sources (1)
- EUDAMED 0598fbed-1517-4d03-829b-7e36bb62bc15 61 fields · synced Jul 15, 2026