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Elite

by Medixdent International 1,000+ variants

Ref ED-125-002

Active European Union

CE MDR

Valid until

No date given

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G359DENTALCUTTINGINST39 Basic UDI-DI +G359ED1250020PUDI-DIDate23 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  • Withdrawn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 Cutting Instruments
Model / reference
ED-125-002
Primary DI / UDI-DI
+G359ED1250020P
Basic UDI-DI
++G359DENTALCUTTINGINST39
EMDN code
Q010399 Surgical dental devices - other
Device class
Class I
EU registration type
Standard device
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

  • Sterilise before use
  • Reusable

Other properties (12)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No