← Back to catalogue
X-Ray Tv System Sonialvision G4
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-10000-43Model X-RAY TV SYSTEM SONIALVISION G4
Identity
- Trade Name
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMEDSONIALVISION G4 EUDAMEDFDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMED
- Model / Reference
- X-RAY TV SYSTEM SONIALVISION G4 EUDAMED566-10000-43 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217041046 EUDAMEDFDA UDI
- Basic UDI-DI
- 45402170100000000000001SL EUDAMEDB-04540217041046 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
X-Ray Tv System Sonialvision G4 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 | 45402170100000000000001SL | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170100000000000001SL | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 10a02750-bc34-42d2-91a7-f4ec02551176 61 fields · synced Aug 2, 2026
- EUDAMED 02059741-7bac-4cd6-9786-000be1624a9c 61 fields · synced May 18, 2026
- FDA UDI 8ce443f1-060b-4314-a544-ad254409cd29 32 fields · synced May 30, 2026