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Coltolux LED Light Curing System, 230/240V China

by Coltene/Whaledent Inc.

Ref C7970230240C

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 Number++D661076L2 Basic UDI-DI D661C7970230240C0UDI-DIDate31 Mar 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
LED Curing Lights
Model / Reference
C7970230240C
Primary DI / UDI-DI
D661C7970230240C0
Basic UDI-DI
++D661076L2
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class I

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Related devices

Category: Dental appliance fabrication material, ceramic

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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