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i600

by Medit Corp. 3 variants

Ref MD-IS0100

i600 (MD-IS0100) is a device classified as Class I in the EU and Class II in the US made by Medit Corp., registered in EUDAMED on 9 Jun 2022 (Basic UDI-DI 88000267MD-IS0100KE) and listed in FDA GUDID since 24 May 2023 (UDI-DI 08800026700098), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800026700098 UDI-DI Date24 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000267MD-IS0100KE Basic UDI-DI 08800026700098UDI-DIDate9 Jun 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MD-IS0100KE registered 9 Jun 2022 Active
  • FDA GUDID UDI-DI 08800026700098 listed 24 May 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 88000267MD-IS0100KE
  2. Listed FDA GUDID 08800026700098

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  • Withdrawn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
MD-IS0100
Primary DI / UDI-DI
08800026700098
Basic UDI-DI
88000267MD-IS0100KE
Direct marketing DI
08800026700098
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.

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Properties

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