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Mobile X-ray System MobileDaRt Evolution
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-20000-06Model Mobile X-ray System MobileDaRt Evolution
Identity
- Trade Name
- Mobile X-ray System MobileDaRt Evolution EUDAMEDMobileDaRt Evolution EUDAMEDTrinias FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- Mobile X-ray System MobileDaRt Evolution EUDAMED
- Model / Reference
- Mobile X-ray System MobileDaRt Evolution EUDAMED566-20000-06 EUDAMED503-79823-43 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217059607 EUDAMEDFDA UDI
- Basic UDI-DI
- 45402170100000000000009T4 EUDAMEDB-04540217059607 EUDAMED
- 510(k) Number
- K123508 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMEDZ11030506 TELERADIOGRAPHS EUDAMED
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mobile X-ray System MobileDaRt Evolution by Shimadzu Corporation — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 45402170100000000000009T4 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170100000000000009T4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED f6524ad5-3902-4535-82ef-5e46073bcd6f 61 fields · synced Jul 20, 2026
- EUDAMED 0ee24ded-b79a-4f15-8922-c09d172110ca 61 fields · synced May 19, 2026
- FDA UDI 821eae0b-1c9e-43c3-8a22-53610d4f5a8f 33 fields · synced May 30, 2026