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MobileDaRt Evolution
EUDAMEDClass IIb (EU MDR)
Ref 566-20000-05Model Mobile X-ray System MobileDaRt Evolution
Identity
- Trade Name
- MobileDaRt Evolution EUDAMEDMobile X-ray System MobileDaRt Evolution EUDAMED
- Device Name
- Mobile X-ray System MobileDaRt Evolution EUDAMED
- Model / Reference
- 566-20000-05 EUDAMEDMobile X-ray System MobileDaRt Evolution EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217059591 EUDAMED
- Basic UDI-DI
- B-04540217059591 EUDAMED45402170100000000000009T4 EUDAMED
- EMDN Code
- Z11030506 TELERADIOGRAPHS EUDAMEDZ11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
MobileDaRt Evolution by Shimadzu Corporation — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540217059591 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217059591 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (2)
- EUDAMED 26d994a5-4fd6-4a39-809a-e2369d33e475 61 fields · synced Jul 28, 2026
- EUDAMED d9179516-ccee-4d21-a3b1-c8bad36ffdc7 61 fields · synced May 18, 2026