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tgDiamond+

by Meta Biomed Co., Ltd. South Korea EUDAMED

Ref -Model Ezfil B1

EMDN Q01010103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08806387861652 Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Dental Composite Resin
Model / Reference
Ezfil B1, -
Primary DI / UDI-DI
08806387861652
Basic UDI-DI
B-08806387861652
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009681
Authorised representative
Meta Biomed Europe GmbH DE-AR-000004953

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (10)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08806387861652|B-08806387861652 61 fields · synced 24 Oct 2026