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Elite

by Medixdent International 1,000+ variants

Ref ED-IMK-14

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G359DentalChiselsKitPC Basic UDI-DI +G359EDIMK140.UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental Chisels Kit
Dental Chisels Set
Model / Reference
ED-IMK-14
Primary DI / UDI-DI
+G359EDIMK140.
Basic UDI-DI
++G359DentalChiselsKitPC, ++G359DCHISELSETSD
EMDN Code
L150102 Odontostomatology chisels, reusable
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
PK-MF-000027173
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Medixdent International

See all devices from Medixdent International →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No