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Amber COLD pink 500 g powder

by Przedsiębiorstwo Usługowo Handlowe Dentex Spółka Z Ograniczoną Odpowiedzialnością

Ref DACP5PXXModel Cold curing denture base polymers

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59069546ARC44 Basic UDI-DI 05906954695345UDI-DIDate15 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Amber Cold - Self-curing acrylic resin for the repair of dental restorations
Model / Reference
Cold curing denture base polymers, DACP5PXX
Primary DI / UDI-DI
05906954695345
Basic UDI-DI
59069546ARC44
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000053337

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Properties

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