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Dental Light

by Alliage S/a Indústrias Médico Odontológica 5 variants

Ref 41000008378Model SIRIUS G8 SENSOR 5 (3X2) LEDS

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 Number78995813DentalLight014CV Basic UDI-DI 07899581344039UDI-DIDate3 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
SIRIUS G8 SENSOR 5 (3X2) LEDS, 41000008378
Primary DI / UDI-DI
07899581344039
Basic UDI-DI
78995813DentalLight014CV
EMDN Code
Z129004 Light sources
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
BR-MF-000016681
Authorised representative
ELS SOLUTIONS GDIA - UNIPESSOAL LDA. PT-AR-000026128

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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