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iE

by Medit Corp.

Ref MO8-iE

iE (MO8-iE) is a device classified as Class I in the EU and Class II in the US made by Medit Corp., registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 88000267MO8-iEFD) and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 08800026701057), 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 Number88000267MO8-iEFD Basic UDI-DI 08800026701057UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026701057 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MO8-iEFD registered 15 Sep 2026 Active
  • FDA GUDID UDI-DI 08800026701057 listed 9 Sep 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026701057
  2. Registered EUDAMED 88000267MO8-iEFD

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  • Withdrawn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
Model / reference
MO8-iE
Primary DI / UDI-DI
08800026701057
Basic UDI-DI
88000267MO8-iEFD
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
EU registration type
Standard device
EU market of registration
Germany
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 08800026701057: 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-000007132
Authorised representative
Meditrial Srl IT-AR-000007805

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Medit Corp.

See all devices from Medit Corp. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)