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hyperion X9 pro
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 70A10000, 70AA0000Model Panoramic, cephalometric and tomographic X-ray equipment510(k) K123381
by CEFLA s.c.
Identity
- Trade Name
- hyperion X9 pro EUDAMEDmyray 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. FDA UDI
- Model / Reference
- Panoramic, cephalometric and tomographic X-ray equipment EUDAMED70A10000, 70AA0000 EUDAMEDhyperion X9 pro FDA UDI
- Description
- Digital panoramic, cephalometric and tomographic extra-oral X-ray system. FDA UDI
Identifiers
- Catalog Number
- 70A10000 FDA UDI
- Primary DI / UDI-DI
- 08033837931881 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYEXB001SY EUDAMED
- Direct Marketing DI
- 08033837931881 EUDAMED
- 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
hyperion X9 pro by CEFLA s.c. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123381 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYEXB001SY | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED 97bea1cd-553e-4ca6-bea3-ebb597fb81d5 85 fields · synced Jun 19, 2026
- FDA UDI 6a69ddea-900c-4363-bc44-96bd80a97b59 36 fields · synced May 25, 2026
- FDA 510(k) K123381 1 fields · synced May 18, 2026