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hyperion X9 pro
EUDAMEDClass IIb (EU MDR)
Ref 70A20000, 70AB0000Model Panoramic, cephalometric and tomographic X-ray equipment
by CEFLA s.c.
Identity
- Trade Name
- hyperion X9 pro EUDAMED
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70A20000, 70AB0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837934950 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837934950 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
hyperion X9 pro 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 (1)
- EUDAMED c29d3292-9911-4d06-a7dc-b91a8fb0927c 61 fields · synced May 23, 2026