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i700

by Medit Corp.

Ref MD-IS0200

i700 (MD-IS0200) is a dental milling system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 25 Jul 2023 (Basic UDI-DI 88000267MD-IS0200KK) and listed in FDA GUDID since 25 Feb 2021 (UDI-DI 08800026700074), 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-IS0200KK Basic UDI-DI 08800026700074UDI-DIDate25 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026700074 UDI-DI Date25 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267MD-IS0200KK registered 25 Jul 2023 Active
  • FDA GUDID UDI-DI 08800026700074 listed 25 Feb 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026700074
  2. Registered EUDAMED 88000267MD-IS0200KK

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  • Withdrawn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
i700 EUDAMEDGUDID
i700 Reusable tip GUDID
Generic name
Dental milling system, CAD/CAM, chairside
Model / reference
MD-IS0200, MD-RT0200
Primary DI / UDI-DI
08800026700074, 08800026700043
Basic UDI-DI
88000267MD-IS0200KK
Direct marketing DI
08800026700074
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
EU registration type
Standard device
EU market of registration
Iceland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08800026700074: EUDAMED states No, FDA GUDID states Yes.

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