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syngo.CT Extended Functionality
EUDAMEDClass IIa (EU MDR)
Ref 11664817Model syngo.CT PP_IIa_App_ERLN H 127
Identity
- Trade Name
- syngo.CT Extended Functionality EUDAMED
- Device Name
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED
- Model / Reference
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED11664817 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869996554 EUDAMED
- Basic UDI-DI
- 0405686900118UT EUDAMED
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
syngo.CT Extended Functionality by Siemens Healthcare GmbH — Class IIa — 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 | 0405686900118UT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (1)
- EUDAMED b2dd2f0b-a0b9-4e4c-993e-750c1b82b5f9 61 fields · synced Oct 5, 2026