← Back to catalogue
syngo Carbon Space
EUDAMEDClass IIb (EU MDR)
Ref 11582642Model MDR_05_FOR_SYNGO_SaMD_IIb
Identity
- Trade Name
- syngo Carbon Space EUDAMED
- Device Name
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED
- Model / Reference
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED11582642 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869275444 EUDAMED
- Basic UDI-DI
- 0405686901978WU EUDAMED
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES 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
syngo Carbon Space by Siemens Healthcare GmbH — Class IIb — CE/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 | 0405686901978WU | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (2)
- EUDAMED 9e545ea8-5317-4a46-bcfc-7a60287a3339 61 fields · synced Oct 7, 2026
- EUDAMED 79f919ef-8529-48cc-8ee6-65ad6a2464e8 61 fields · synced Jul 23, 2026