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RADspeed Pro
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-18100-06Ref 566-18100-02Ref 566-26000-52Model RADspeed ProRef 566-26000-51Ref 566-26000-50Ref 566-18100-23
Identity
- Trade Name
- RADspeed Pro EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Digital Radiography System RADspeed Pro EUDAMED
- Model / Reference
- 566-18100-06 EUDAMED566-18100-02 EUDAMEDRADspeed Pro EUDAMED566-26000-52 EUDAMED566-26000-51 EUDAMED566-26000-50 EUDAMEDFDA UDI566-18100-23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217052264 EUDAMED04540217052240 EUDAMED04540217073849 EUDAMED04540217073832 EUDAMED04540217071319 EUDAMEDFDA UDI04540217052295 EUDAMED
- Basic UDI-DI
- B-04540217052264 EUDAMEDB-04540217052240 EUDAMED45402170100000000000003SQ EUDAMEDB-04540217052295 EUDAMED
- 510(k) Number
- K233722 FDA UDI
- FDA Product Code
- MQB FDA UDIKPR FDA UDI
- EMDN Code
- Z11030506 TELERADIOGRAPHS EUDAMEDZ11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 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
No
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
RADspeed Pro 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 | B-04540217052264 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-04540217052264 | 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 (7)
- EUDAMED d8853d9c-8080-4b43-9f50-0b8be8b421b6 61 fields · synced Jul 30, 2026
- EUDAMED 84c58c1c-f7c6-4629-8cac-a9e54fbb8a9f 61 fields · synced May 16, 2026
- EUDAMED ad00dd11-7bac-428b-882c-bbf3202baf5a 61 fields · synced May 17, 2026
- EUDAMED 759de88e-a860-412d-9607-c5a277b0bd37 61 fields · synced May 17, 2026
- EUDAMED 9f09504c-139b-42a5-9cd3-bffdc2fcf1c9 61 fields · synced May 18, 2026
- EUDAMED 012048c4-1f0e-421b-888a-fd5a71672ccb 61 fields · synced May 18, 2026
- FDA UDI bdebb2ca-4670-4552-b578-d0d2c16b3946 33 fields · synced May 30, 2026