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i900

by Medit Corp. 2 variants

Ref MO1-RTS

i900 (MO1-RTS) is a dental milling system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 7 Mar 2024 (Basic UDI-DI 88000267MO1-RTSDX) and listed in FDA GUDID since 9 Apr 2024 (UDI-DI 08800026700395), 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
United StatesGUDID listing GUDID Number08800026700395 UDI-DI Date9 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000267MO1-RTSDX Basic UDI-DI 08800026700395UDI-DIDate7 Mar 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MO1-RTSDX registered 7 Mar 2024 Active
  • FDA GUDID UDI-DI 08800026700395 listed 9 Apr 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 88000267MO1-RTSDX
  2. Listed FDA GUDID 08800026700395

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  • Withdrawn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
i900 EUDAMED
Reusable Tip (Small) GUDID
Generic name
Dental milling system, CAD/CAM, chairside
Device name
i900 Reusable Tip (Small)
Model / reference
MO1-RTS
Primary DI / UDI-DI
08800026700395
Basic UDI-DI
88000267MO1-RTSDX
Direct marketing DI
08800026700395
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
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

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
  • Prescription use
  • Premarket exempt
Other properties (22, all answered No)