Identity
- Trade Name
- iQ-ROUTER 5.0 EUDAMED
- Device Name
- iQ-SYSTEM PACS EUDAMED
- Model / Reference
- IQROUTER50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B403IQROUTER5001 EUDAMED
- Basic UDI-DI
- ++B403IQSYSTEMPACS1YG EUDAMED
- Direct Marketing DI
- +B403IQROUTER5001 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
iQ-ROUTER 5.0 by IMAGE INFORMATION SYSTEMS EUROPE GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B403IQSYSTEMPACS1YG | Class IIb | Active |
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Manufacturer
- Manufacturer
- IMAGE Information Systems Europe GmbH
- EUDAMED SRN
- DE-MF-000004979
Sources (1)
- EUDAMED 68243f08-822a-4030-99e9-34f0452e060f 61 fields · synced Jul 11, 2026