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Mobile X-ray System MobileDaRt Evolution
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 566-20000-55Model Mobile X-ray System MobileDaRt Evolution510(k) K080701Ref 566-20000-45
Identity
- Trade Name
- Mobile X-ray System MobileDaRt Evolution EUDAMED
- Model / Reference
- Mobile X-ray System MobileDaRt Evolution EUDAMED566-20000-55 EUDAMED566-20000-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217072637 EUDAMED04540217072606 EUDAMED
- Basic UDI-DI
- 45402170100000000000009T4 EUDAMED
- EMDN Code
- Z11030599 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
Mobile X-ray System MobileDaRt Evolution by Shimadzu Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080701 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170100000000000009T4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- FDA Applicant
- Shimadzu Corp.
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 4940e93d-fbbc-4719-bbea-d340e1708a50 85 fields · synced Jul 14, 2026
- EUDAMED 60a63557-6664-4e4e-a912-87b705fe384b 61 fields · synced May 18, 2026
- FDA 510(k) K080701 1 fields · synced May 18, 2026