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EOS Compact
EUDAMEDClass IIb (EU MDR)
Ref 70EG0000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70EN0000Ref 70EH0000Ref 70EI0000
by CEFLA s.c.
Identity
- Trade Name
- EOS Compact EUDAMED
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70EG0000 EUDAMED70EN0000 EUDAMED70EH0000 EUDAMED70EI0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837936176 EUDAMED08033837936794 EUDAMED08033837936411 EUDAMED08033837936428 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837936176 EUDAMED08033837936794 EUDAMED08033837936411 EUDAMED08033837936428 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
EOS Compact 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 (4)
- EUDAMED 9d310294-72ae-4760-8fc1-ab0109949872 61 fields · synced Jul 24, 2026
- EUDAMED ff9b6fcf-79a4-4cae-948a-2474e067fad4 61 fields · synced May 17, 2026
- EUDAMED 83da218b-a461-4025-98cd-b1ed42620bc5 61 fields · synced May 18, 2026
- EUDAMED 80aa8b36-ae20-4a2a-8024-cc92020c2bc8 61 fields · synced May 18, 2026