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Luna 2 20 Comp B2

by SDI Limited EUDAMED

Active European Union

Ref 8452057Model Dental material, filling/restorative, polymer based

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9336472110335870B1GN Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Luna Flow LV
Model / Reference
Dental material, filling/restorative, polymer based, 8452057
Primary DI / UDI-DI
09336472028091
Basic UDI-DI
9336472110335870B1GN
Direct Marketing DI
09336472028091
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000024633
Authorised representative
SDI Germany GmbH DE-AR-000023386

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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