Identity
- Trade Name
- OTOPLAN EUDAMED
- Device Name
- OTOPLAN EUDAMED
- Model / Reference
- 20072 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07616962000205 EUDAMED
- Basic UDI-DI
- 764016722300OPL001Z7 EUDAMED
- Direct Marketing DI
- 07616962000205 EUDAMED
- EMDN Code
- Z12140592 STEREOTACTIC ENT SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Otoplan by CAScination AG — 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 | 764016722300OPL001Z7 | Class IIa | 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 49a49129-8b84-4729-873e-347faed0266e 61 fields · synced Jun 18, 2026