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Sonialvision G4
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-10000-42Model X-RAY TV SYSTEM SONIALVISION G4
Identity
- Trade Name
- SONIALVISION G4 EUDAMEDFDA UDIX-RAY TV SYSTEM SONIALVISION G4 EUDAMED
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMED
- Model / Reference
- 566-10000-42 EUDAMEDFDA UDIX-RAY TV SYSTEM SONIALVISION G4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217041039 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217041039 EUDAMED45402170100000000000001SL EUDAMED
- FDA Product Code
- JAA FDA UDI
- EMDN Code
- Z11030702 DIGITAL REMOTE CONTROL TABLES EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic 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
Sonialvision G4 by Shimadzu Corporation — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540217041039 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217041039 | 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 7cf96376-3a29-4dc1-81cd-cdf9795ae37c 61 fields · synced Jul 13, 2026
- EUDAMED 054b5d2a-56f9-417d-a309-4c33db963f77 61 fields · synced May 19, 2026
- FDA UDI ffa68db9-fe15-4875-9c8a-7b0d82443cff 32 fields · synced May 30, 2026