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Palaseal

by KULZER GmbH EUDAMED

Active European Union

Ref 000000000064710614

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++J0141209DEBM0699lBA Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Model / Reference
000000000064710614
Primary DI / UDI-DI
+J014647106140
Basic UDI-DI
++J0141209DEBM0699lBA
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
DE-MF-000007705

Other devices from Kulzer, Inc.

See all devices from Kulzer, Inc. →

Properties

  • CMR Substance

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No