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54F2PP04

by bredent GmbH & Co. KG Germany EUDAMED

Ref 54F2PP04Model thermoplastic polymer, BioHPP

EMDN Q0102050199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EBRE2aResinBioHPPNZ Basic UDI-DIDate22 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
thermoplastic polymer, BioHPP, 54F2PP04
Primary DI / UDI-DI
+EBRE54F2PP040F
Basic UDI-DI
++EBRE2aResinBioHPPNZ
EMDN Code
Q0102050199 Dentistry resins - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008124

Other devices from Bredent GmbH & Co.KG

See all devices from Bredent GmbH & Co.KG →

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (12)
  • Sterile: 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 +EBRE54F2PP040F|++EBRE2ARESINBIOHPPNZ 61 fields · synced 25 Oct 2026