Identity
- Trade Name
- CAS-One IR Baseplate A EUDAMED
- Device Name
- CAS-One IR Baseplate EUDAMED
- Model / Reference
- 30238 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07616962000168 EUDAMED
- Basic UDI-DI
- 764016722122C1R006LF EUDAMED
- Direct Marketing DI
- 07616962000168 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - 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
Category: Neurological stereotactic surgery system
CAS-One IR Baseplate A by CAScination AG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K232022 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K152473 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 764016722122C1R006LF | 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 (2)
- EUDAMED b63c6915-e3cd-4cab-bcdc-cb4c71f53f2a 61 fields · synced Jul 14, 2026
- FDA 510(k) K232022 1 fields · synced May 18, 2026