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opt-on 3.3

by orangedental GmbH & Co. KG

Ref 4260375690107 / lup0499100

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426037569lup0499000CG Basic UDI-DI 04260375690107UDI-DIDate20 Oct 2021RegisteredStatusActive

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  • Withdrawn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
opt-on
Model / Reference
4260375690107 / lup0499100
Primary DI / UDI-DI
04260375690107
Basic UDI-DI
426037569lup0499000CG
Direct Marketing DI
04260375690107
EMDN Code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006152

Related devices

Category: Fixture/appliance dental drill bit, reusable

Other devices from orangedental GmbH & Co. KG

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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