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i700 wireless

by Medit Corp.

Ref MD-IS0300

i700 wireless (MD-IS0300) is a dental milling system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 17 Jun 2022 (Basic UDI-DI 88000267MD-IS0300KQ) and listed in FDA GUDID since 15 Nov 2021 (UDI-DI 08800026700067), 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
European UnionCE/MDR EUDAMED Number88000267MD-IS0300KQ Basic UDI-DI 08800026700067UDI-DIDate17 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026700067 UDI-DI Date15 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MD-IS0300KQ registered 17 Jun 2022 Active
  • FDA GUDID UDI-DI 08800026700067 listed 15 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026700067
  2. Registered EUDAMED 88000267MD-IS0300KQ

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  • Withdrawn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-IS0300
Primary DI / UDI-DI
08800026700067
Basic UDI-DI
88000267MD-IS0300KQ
Direct marketing DI
08800026700067
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

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Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

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