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hyperion X5
EUDAMEDClass IIb (EU MDR)
Ref 70BC0000, 70B1C000Model Panoramic, cephalometric and tomographic X-ray equipment
by CEFLA s.c.
Identity
- Trade Name
- hyperion X5 EUDAMED
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70BC0000, 70B1C000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935568 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837935568 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 X5 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 ea37aa19-5706-4a7a-bf3f-29cdd973a3be 61 fields · synced May 23, 2026