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i500 Reusable tip MD-RT0100

by Medit Corp.

i500 Reusable tip MD-RT0100 is a dental milling system (FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED and listed in FDA GUDID since 16 Nov 2021 (UDI-DI 08800026700081), 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
United StatesGUDID listing GUDID Number08800026700081 UDI-DI Date16 Nov 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 08800026700081 listed 16 Nov 2021 Listed

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  • Withdrawn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
i500 Reusable tip
Generic name
Dental milling system, CAD/CAM, chairside
Model / reference
MD-RT0100
Primary DI / UDI-DI
08800026700081
FDA product code
NOF
GMDN term
Dental milling system, CAD/CAM, chairside
Device class
Class II
Regulation number
872.3661
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code NOF (System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations).

Other devices from Medit Corp.

See all devices from Medit Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (11, all answered No)