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i900 classic

by Medit Corp.

Ref MO4-i900c

i900 classic (MO4-i900c) is a device classified as Class I in the EU and Class II in the US made by Medit Corp., registered in EUDAMED on 6 Feb 2025 (Basic UDI-DI 88000267MO4-i900cV6) and listed in FDA GUDID since 22 May 2025 (UDI-DI 08800026700623), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800026700623 UDI-DI Date22 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000267MO4-i900cV6 Basic UDI-DI 08800026700623UDI-DIDate6 Feb 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MO4-i900cV6 registered 6 Feb 2025 Active
  • FDA GUDID UDI-DI 08800026700623 listed 22 May 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 88000267MO4-i900cV6
  2. Listed FDA GUDID 08800026700623

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  • Withdrawn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 milling system, CAD/CAM, chairside
Model / reference
MO4-i900c
Primary DI / UDI-DI
08800026700623
Basic UDI-DI
88000267MO4-i900cV6
Direct marketing DI
08800026700623
FDA product code
NOF
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental milling system, CAD/CAM, chairside
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
System or procedure pack
System which is a device in itself
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
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

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

  • Supplied sterile UDI-DI 08800026700623: EUDAMED states Yes, FDA GUDID states No.

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

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (20, all answered No)