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RADspeed Pro
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-26000-61Model RADspeed Pro
Identity
- Trade Name
- RADspeed Pro EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Model / Reference
- RADspeed Pro EUDAMED566-26000-61 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217071357 EUDAMEDFDA UDI
- Basic UDI-DI
- 45402170100000000000003SQ EUDAMED
- 510(k) Number
- K233722 FDA UDI
- FDA Product Code
- MQB FDA UDIKPR FDA UDI
- EMDN Code
- Z11030599 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 45402170100000000000003SQ | 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 (2)
- EUDAMED 054c0c28-a18b-4d9a-a73b-d57497951a9b 61 fields · synced May 30, 2026
- FDA UDI bc41fe30-2074-4d2c-b713-4869cfb481cb 33 fields · synced May 30, 2026