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ProXIma X6

EUDAMED

Class IIb (EU MDR)

Ref 70EA0000Model Panoramic, cephalometric and tomographic X-ray equipmentRef 70EJ0000Ref 70EB0000Ref 70EC0000

by CEFLA s.c.

Identity

Trade Name
ProXIma X6 EUDAMED
Model / Reference
Panoramic, cephalometric and tomographic X-ray equipment EUDAMED
70EA0000 EUDAMED
70EJ0000 EUDAMED
70EB0000 EUDAMED
70EC0000 EUDAMED

Identifiers

Primary DI / UDI-DI
08033837934981 EUDAMED
08033837936756 EUDAMED
08033837935001 EUDAMED
08033837936084 EUDAMED
Basic UDI-DI
803383793IMXRAYEXB001SY EUDAMED
Direct Marketing DI
08033837934981 EUDAMED
08033837936756 EUDAMED
08033837935001 EUDAMED
08033837936084 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

ProXIma X6 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

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Manufacturer

Manufacturer
CEFLA s.c.
EUDAMED SRN
IT-MF-000009228

Sources (4)

  • EUDAMED a66bcb76-1845-48b2-8cc2-b562a5333bdd 61 fields · synced Aug 3, 2026
  • EUDAMED 11b2836d-1674-4039-a2ba-698b809987a0 61 fields · synced May 17, 2026
  • EUDAMED 38ca64e0-dcfa-4cc4-bf3c-f782d946d1f9 61 fields · synced May 18, 2026
  • EUDAMED 0a38c4a8-a397-43c4-8bc2-43e8051f3278 61 fields · synced Jul 22, 2026