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FDR Visionary Suite
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-16130-80Model FDR Visionary Suite
Identity
- Trade Name
- FDR Visionary Suite EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Model / Reference
- FDR Visionary Suite EUDAMED566-16130-80 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217071586 EUDAMEDFDA UDI
- Basic UDI-DI
- 45402170100000000000012SR EUDAMED
- 510(k) Number
- K233719 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
FDR Visionary Suite 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 | 45402170100000000000012SR | 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 716d7dc1-70bc-44e6-a751-c17d82e6da8e 61 fields · synced Jun 6, 2026
- FDA UDI 4290a8b6-7815-418d-803f-39ec1ac1fca8 33 fields · synced May 30, 2026