Skip to content

ProXIma X6

by CEFLA s.c. 2 variants

Ref 70EB0000Model Panoramic, cephalometric and tomographic X-ray equipment

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08033837935001 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number803383793IMXRAYEXB001SY Basic UDI-DI 08033837935001UDI-DIDate13 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ProXIma X6 EUDAMED
myray GUDID
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
Panoramic, cephalometric and tomographic X-ray equipment, 70EB0000, ProXIma X6 (3D)
Primary DI / UDI-DI
08033837935001
Basic UDI-DI
803383793IMXRAYEXB001SY
Direct Marketing DI
08033837935001
510(k) Number
FDA Product Code
MUH, OAS
EMDN Code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.1800, 892.1750
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Panoramic, cephalometric and tomographic X-ray equipment
70EB0000
GUDID
ProXIma X6 (3D)
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000009228

Other devices from CEFLA s.c.

See all devices from CEFLA s.c. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No