Identity
- Trade Name
- SICAT AIR V2.0.40 EUDAMEDSICAT Air FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- SICAT Air EUDAMED
- Model / Reference
- 10271501 EUDAMED2.0.40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D776AIRV20400 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D776AIRTN EUDAMED
- 510(k) Number
- K152661 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sicat Air V2.0.40 by SICAT GmbH & Co. KG — Class IIa — 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 | ++D776AIRTN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SICAT GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005604
Sources (2)
- EUDAMED 60f097f1-cb97-465f-8082-1c8c638978b0 61 fields · synced Jul 12, 2026
- FDA UDI cd49e437-6692-4c12-bdd3-131d49d9714d 33 fields · synced May 29, 2026