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i500

by Medit Corp.

Ref i500

i500 is a dental milling system (EU MDR Class I; FDA Class II; FDA product code NOF) made by Medit Corp., registered in EUDAMED on 14 Jun 2022 (Basic UDI-DI 88000267i500M7) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 08800026700012), 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 Number88000267i500M7 Basic UDI-DI 08800026700012UDI-DIDate14 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800026700012 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000267i500M7 registered 14 Jun 2022 Active
  • FDA GUDID UDI-DI 08800026700012 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800026700012
  2. Registered EUDAMED 88000267i500M7

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  • Withdrawn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 EUDAMED
Medit GUDID
Generic name
Dental milling system, CAD/CAM, chairside
Model / reference
i500
Primary DI / UDI-DI
08800026700012
Basic UDI-DI
88000267i500M7
Direct marketing DI
08800026700012
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
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

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

Registry differences

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

  • Sterilise before use UDI-DI 08800026700012: EUDAMED states Yes, FDA GUDID states No.

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