Identity
- Trade Name
- aycan workstation EUDAMEDFDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- aycan PACS EUDAMED
- Model / Reference
- aycan workstation EUDAMEDv3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260476510021 EUDAMEDFDA UDI
- Basic UDI-DI
- 42604765aycanPACSHA EUDAMED
- Direct Marketing DI
- 04260476510021 EUDAMED
- 510(k) Number
- K103546 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS 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
No
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
aycan workstation by Aycan Digitalsysteme Gmbh — 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 | 42604765aycanPACSHA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- aycan Digitalsysteme GmbH
- EUDAMED SRN
- DE-MF-000006951
Sources (2)
- EUDAMED 8d9fafc8-4969-4017-a0b1-a8e988f46237 61 fields · synced Oct 7, 2026
- FDA UDI 0c0c2cfb-2fc9-4209-b6ba-06e6cd1ecacf 33 fields · synced May 30, 2026