Identity
- Trade Name
- iQ-LITE 3.0.0 EUDAMED
- Device Name
- iQ-LITE 3.0.0 EUDAMED
- Model / Reference
- IQLITE300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000004979LITE300NJ EUDAMED
- Basic UDI-DI
- B-DEMF000004979LITE300NJ EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iQ-LITE 3.0.0 by IMAGE INFORMATION SYSTEMS EUROPE GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-DEMF000004979LITE300NJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- IMAGE Information Systems Europe GmbH
- EUDAMED SRN
- DE-MF-000004979
Sources (1)
- EUDAMED 07b5ce73-acd0-4819-a9f4-73f6a6215fe3 61 fields · synced Jun 20, 2026