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Duradent - Duralux Düz - Orak - Sond

by Erk Dental Med. Tibbi̇. Malz. Tur. San. Ve Ti̇c. Ltd. Şti̇.

Ref 0005Model DURALUX DÜZ - ORAK

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, self-declared

Class I: no certifier involved

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 Number869919750005SA Basic UDI-DI 08699197580536UDI-DIDate16 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sond
Model / Reference
DURALUX DÜZ - ORAK, 0005
Primary DI / UDI-DI
08699197580536
Basic UDI-DI
869919750005SA
EMDN Code
L159003 Dental and periodontal probes and explorers, reusable
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038674

Other devices from Erk Dental Med. Tibbi̇. Malz. Tur. San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Erk Dental Med. Tibbi̇. Malz. Tur. San. Ve Ti̇c. Ltd. Şti̇. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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