Identity
- Trade Name
- CAS-One IR Software EUDAMEDFDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- CAS-One IR Software EUDAMED
- Model / Reference
- 20016 EUDAMED4.1 FDA UDI
Identifiers
- Catalog Number
- 20016 FDA UDI
- Primary DI / UDI-DI
- 07616962000281 EUDAMED07616962000335 EUDAMED07616962000236 EUDAMED07616962000250 FDA UDI
- Basic UDI-DI
- 764016722300C1R001KB EUDAMED
- Direct Marketing DI
- 07616962000335 EUDAMED07616962000236 EUDAMED
- 510(k) Number
- K232022 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z12011492 SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 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
CAS-One IR Software by CAScination AG — Class IIb — 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 | 764016722300C1R001KB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cascination Ag
- EUDAMED SRN
- CH-MF-000009927
- Authorised Representative
- CAScination Deutschland GmbH DE-AR-000008247
Sources (4)
- EUDAMED f9d50d07-bda6-48f8-b888-de0607a4c237 61 fields · synced Jul 17, 2026
- FDA UDI 85a5a7a2-32de-469e-92a2-a96616c42787 34 fields · synced May 30, 2026
- EUDAMED d7c10b42-b99f-4e83-8a49-4bcf7620d6be 61 fields · synced Jul 16, 2026
- EUDAMED 95e9c72e-1864-4108-9856-24d5096b565f 61 fields · synced Jul 17, 2026