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R2i5

by MegaGen Implant Co., Ltd.

Ref 3DS Mega

R2i5 (3DS Mega) 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 3 Dec 2025 (UDI-DI 08800293009726), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899753A Basic UDI-DI 08800293009726UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800293009726 UDI-DI Date3 Dec 2025ListedStatusListed 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 08800293009726 listed 3 Dec 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800293009726
  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  • Withdrawn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

Generic name
Intraoral optical scanning system
Device name
Intraoral Scanner
Model / reference
3DS Mega
Primary DI / UDI-DI
08800293009726
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08800293009726: EUDAMED states No, FDA GUDID states Yes.

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.

Manufacturer details

EUDAMED SRN
KR-MF-000009885
Authorised representative
MDSS GmbH DE-AR-000005430

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

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)