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X-RADiUS TRiO PLUS
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 70A50000, 70AE0000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70A60000, 70AF0000
by CEFLA s.c.
Identity
- Trade Name
- X-RADiUS TRiO PLUS EUDAMEDCastellini FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70A50000, 70AE0000 EUDAMED70A60000, 70AF0000 EUDAMEDX-RADiUS TRiO PLUS FDA UDI
- Description
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. FDA UDI
Identifiers
- Catalog Number
- 70A50000 FDA UDI
- Primary DI / UDI-DI
- 08033837931904 EUDAMEDFDA UDI08033837934974 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837931904 EUDAMED08033837934974 EUDAMED
- FDA Product Code
- MUH FDA UDIOAS FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI892.1750 FDA UDI
- Market of Registration
- Italy 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
Yes
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
X-RADiUS TRiO PLUS by CEFLA s.c. — 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 | 803383793IMXRAYEXB001SY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (4)
- EUDAMED 5a1cd2e7-aaa9-4694-8dcd-d042f236f37a 61 fields · synced Jul 9, 2026
- EUDAMED 627977e7-b527-4fd7-9c23-556e970396dc 61 fields · synced May 17, 2026
- FDA UDI 5e0cd410-a972-4b91-9087-6333d14d093e 36 fields · synced May 25, 2026
- EUDAMED 5a1cd2e7-aaa9-4694-8dcd-d042f236f37a-1 61 fields · synced Jul 9, 2026