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iRay iScan

by iRay Group

Ref 03160179Model iScan

iRay iScan is a device classified as Class I in the EU and Class II in the US made by iRay Group, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 697056909ORALSCANNERY8) and listed in FDA GUDID since 13 Jan 2026 (UDI-DI 06970569090993), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697056909ORALSCANNERY8 Basic UDI-DI 06970569090993UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970569090993 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697056909ORALSCANNERY8 registered 15 Jun 2026 Active
  • FDA GUDID UDI-DI 06970569090993 listed 13 Jan 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06970569090993
  2. Registered EUDAMED 697056909ORALSCANNERY8

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  • Withdrawn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
iRay
Generic name
Intraoral optical scanning system
Model / reference
iScan, 03160179
Primary DI / UDI-DI
06970569090993
Basic UDI-DI
697056909ORALSCANNERY8
Direct marketing DI
06970569090993
FDA product code
NOF
EMDN code
Q0199 Odontology devices - other
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from iRay Group

See all devices from iRay Group →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)