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Bulk, Holder, Vert BW, DEXIS IXS Size 2

by Dental Imaging Technologies Corporation

Ref 8.000.4820

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberD090800048120 UDI-DI Date10 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++D090ClassIJE Basic UDI-DI D090800048120UDI-DIDate22 May 2026RegisteredStatusActive

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.

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  • Withdrawn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

Generic Name
Dental x-ray film holder, reusable
Device Name
Intraoral Positioning System
Model / Reference
8.000.4820
Primary DI / UDI-DI
D090800048120
Basic UDI-DI
++D090ClassIJE
FDA Product Code
EGZ
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Dental x-ray film holder, reusable
Device Class
Class I
Regulation Number
872.1905
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000017139
Authorised representative
PaloDEx Group Oy FI-AR-000004955

Other devices from Dental Imaging Technologies Corporation

See all devices from Dental Imaging Technologies Corporation →

Properties

  • Premarket Exempt
  • Lot / Batch 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No