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X-RADiUS COMPACT
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 70BH0000, 70B3H000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70BG0000, 70B3G000Ref 70BI0000, 70B3I000
by CEFLA s.c.
Identity
- Trade Name
- X-RADiUS COMPACT 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. Cephalometric arm is optional. FDA UDIDigital panoramic, cephalometric extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70BH0000, 70B3H000 EUDAMED70BG0000, 70B3G000 EUDAMED70BI0000, 70B3I000 EUDAMEDX-RADiUS COMPACT (3D CEPH) FDA UDIX-RADiUS COMPACT (2D CEPH) FDA UDI
- Description
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. Cephalometric arm is optional. FDA UDIDigital panoramic, cephalometric extra-oral X-ray system. Cephalometric arm is optional. FDA UDI
Identifiers
- Catalog Number
- 70BH0000 FDA UDI70BG0000 FDA UDI
- Primary DI / UDI-DI
- 08033837932895 EUDAMEDFDA UDI08033837932932 EUDAMEDFDA UDI08033837935575 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837932895 EUDAMED08033837932932 EUDAMED08033837935575 EUDAMED
- 510(k) Number
- K200688 FDA UDI
- 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 COMPACT 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 (7)
- EUDAMED e31f19db-dd1c-4416-8b65-f28dfeba77fd 61 fields · synced Aug 3, 2026
- EUDAMED 3ee7ac50-d531-47a9-9455-0922fcb6aa6b 61 fields · synced May 18, 2026
- FDA UDI cce81355-60bf-45ad-8e25-40b0f8ea194e 37 fields · synced May 29, 2026
- FDA UDI f225c556-94f7-4b74-b485-f08dc1cade00 37 fields · synced May 30, 2026
- EUDAMED 3ee7ac50-d531-47a9-9455-0922fcb6aa6b-1 61 fields · synced Jul 28, 2026
- EUDAMED d145c870-4189-4397-b3df-a11155240085-1 61 fields · synced Aug 3, 2026
- EUDAMED d145c870-4189-4397-b3df-a11155240085-2 61 fields · synced Aug 3, 2026