← Back to catalogue
syngo.MR Application
EUDAMEDClass IIb (EU MDR)
Ref 11823214Model MDR_05_FOR_SYNGO_SaMD_IIb
Identity
- Trade Name
- syngo.MR Application EUDAMED
- Device Name
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED
- Model / Reference
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED11823214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04068151008838 EUDAMED
- Basic UDI-DI
- 0405686901978WU EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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.MR Application 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 (1)
- EUDAMED 26e722a0-7121-4bc8-b1e8-c80445d23ccd 61 fields · synced Oct 7, 2026