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i600

by Medit Corp. 3 variants

Ref MD-RT0400

i600 (MD-RT0400) is a dental milling system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 10 Jan 2023 (Basic UDI-DI 88000267MD-RT0400PV) and listed in FDA GUDID since 24 May 2023 (UDI-DI 08800026700111), 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 Number08800026700111 UDI-DI Date24 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000267MD-RT0400PV Basic UDI-DI 08800026700111UDI-DIDate10 Jan 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MD-RT0400PV registered 10 Jan 2023 Active
  • FDA GUDID UDI-DI 08800026700111 listed 24 May 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 88000267MD-RT0400PV
  2. Listed FDA GUDID 08800026700111

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  • Withdrawn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
i600 EUDAMED
Small Tip GUDID
Generic name
Dental milling system, CAD/CAM, chairside
Model / reference
MD-RT0400
Primary DI / UDI-DI
08800026700111
Basic UDI-DI
88000267MD-RT0400PV
Direct marketing DI
08800026700111
FDA product code
NOF
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental milling system, CAD/CAM, chairside
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3661
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

Related devices

Category: Dental appliance fabrication material, ceramic

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Medit Corp.

See all devices from Medit Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (20, all answered No)