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Basis Elast

by Yamahachi Dental Mfg., Co. Japan EUDAMED

Ref 30G,MARBLE α

EMDN Q0102050199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D08016730EL9JJ Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000198 Amended

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    31 Jul 2026
    Expires
    12 Jun 2031
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
30G, MARBLE α
Primary DI / UDI-DI
D080XXBELX30GXXMBA0
Basic UDI-DI
++D08016730EL9JJ
EMDN Code
Q0102050199 Dentistry resins - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED D080XXBELX30GXXMBA0|++D08016730EL9JJ 61 fields · synced 24 Oct 2026