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X-3iO
EUDAMEDClass IIb (EU MDR)
Ref 70BQ0000, 70B6Q000Model Panoramic, cephalometric and tomographic X-ray equipment
by CEFLA s.c.
Identity
- Trade Name
- X-3iO EUDAMED
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70BQ0000, 70B6Q000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935490 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837935490 EUDAMED
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
X-3iO by CEFLA s.c. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYEXB001SY | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED 27fae344-48bf-4e41-a154-278d4c67dfcb 61 fields · synced Jun 18, 2026
- EUDAMED 27fae344-48bf-4e41-a154-278d4c67dfcb-1 61 fields · synced Jun 10, 2026