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R2i3 IOS-11

by Megagen Implant Co. Ltd

Ref IOS-11

R2i3 IOS-11 is an intraoral optical scanning system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Megagen Implant Co. Ltd, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 880972899753A) and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 08809985650987), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899753A Basic UDI-DI 08809985650987UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809985650987 UDI-DI Date26 Jun 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899753A registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 08809985650987 listed 26 Jun 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809985650987
  2. Registered EUDAMED 880972899753A

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  • Withdrawn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
R2i3
Generic name
Intraoral optical scanning system
Device name
Intraoral Scanner
Model / Ref / Catalog
IOS-11
Primary DI / UDI-DI
08809985650987
Basic UDI-DI
880972899753A
FDA product code
NOF
EMDN code
Z12119099 Various dental stomatology instruments - other
GMDN term
Intraoral optical scanning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
EU registration type
Standard device
EU market of registration
Netherlands
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.

Related devices

Category: Intraoral optical scanning system

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER.

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)