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Fusion I-Seal

by Prevest Denpro Limited India EUDAMED

Ref 30028Model Sealant, Liner and Base Material

EMDN Q01010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+D9673002803 Basic UDI-DIDate6 Aug 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

Model / Reference
Sealant, Liner and Base Material, 30028
Primary DI / UDI-DI
+D9673002803
Basic UDI-DI
B-+D9673002803
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class IIa
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
IN-MF-000011546
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: 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 +D9673002803|B-+D9673002803 61 fields · synced 24 Oct 2026