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syngo.CT CaScoring
EUDAMEDClass IIa (EU MDR)
Ref 11546402Model syngo.CT PP_IIa_App_ERLN H 127
Identity
- Trade Name
- syngo.CT CaScoring EUDAMED
- Device Name
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED
- Model / Reference
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED11546402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869290355 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
Category: Full-body CT system
syngo.CT CaScoring by Siemens Healthcare GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 99951f4b-3e6c-4719-bf78-b6d86414baa5 61 fields · synced Jul 22, 2026