Identity
- Trade Name
- OTOPLAN EUDAMEDFDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- OTOPLAN EUDAMED
- Model / Reference
- 20072 EUDAMED1.3 FDA UDI
Identifiers
- Catalog Number
- 20072 FDA UDI
- Primary DI / UDI-DI
- 07640167220724 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016722300OPL001Z7 EUDAMED
- 510(k) Number
- K203486 FDA UDI
- FDA Product Code
- QQE FDA UDI
- EMDN Code
- Z12140592 STEREOTACTIC ENT SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Otoplan by CAScination AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220300 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242120 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203486 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 764016722300OPL001Z7 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cascination Ag
- EUDAMED SRN
- CH-MF-000009927
- Authorised Representative
- CAScination Deutschland GmbH DE-AR-000008247
Sources (3)
- EUDAMED 9d9f61cb-6888-498f-9511-6c74c54ee5c0 61 fields · synced Jul 26, 2026
- FDA UDI a8d10607-3225-4226-8ce6-9e45c44785e1 34 fields · synced May 30, 2026
- FDA 510(k) K220300 1 fields · synced May 18, 2026