Identity
- Trade Name
- CAS-One IR Consumable Set General EUDAMEDFDA UDI
- Generic Name
- Surgical optical-tracking spatial marker, single-use FDA UDI
- Device Name
- CAS-One IR Consumable Set EUDAMED
- Model / Reference
- 50002 EUDAMED2.0 FDA UDI
Identifiers
- Catalog Number
- 50002 FDA UDI
- Primary DI / UDI-DI
- 07640167220021 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016722400C1R001L2 EUDAMED
- 510(k) Number
- K232022 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical optical-tracking spatial marker, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Medical Purpose
- None, that is, none of the devices contained in the procedure pack have a medical purpose. The procedure pack is intended to facilitate the CAS-One IR procedure, that is, an image-guided, percutaneous intervention using the CAS-One IR Software in combination with medical devices and accessories for medical devices. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CAS-One IR Consumable Set General by CAScination AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016722400C1R001L2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cascination Ag
- EUDAMED SRN
- CH-PR-000010324
Sources (2)
- EUDAMED c751d5bf-c684-4e93-a257-80059eaa5247 61 fields · synced Jun 18, 2026
- FDA UDI 903f8ae0-1d03-4a6f-b23b-775d28b038d5 34 fields · synced May 30, 2026