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Fidelity

by Davis Schottlander & Davis Ltd United Kingdom EUDAMED

Ref 0858-20Model Fidelity 25 Saver Pack (PK20), Alginate Impression Materials

EMDN Q01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05052674120633 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive
European UnionCE/MDD NumberB-05052674120633 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Trade Name
Fidelity
Fidelity 25 Saver Pack (PK20)
Device Name
0858-20
Alginate Mat.
Model / Reference
Fidelity 25 Saver Pack (PK20), 0858-20, Alginate Impression Materials
Primary DI / UDI-DI
05052674120633
Basic UDI-DI
B-05052674120633, 5052674ALG-IMP-MATR4
EMDN Code
Q01020101 Dental impression alginates
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000035008
Authorised representative
Schottlander (IRL) Ltd IE-AR-000029625

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 400d37cb-31eb-4db3-ae5e-3016cf38f45f 61 fields · synced 23 Oct 2026
  • EUDAMED 05052674120633|5052674ALG-IMP-MATR4 61 fields · synced 19 Jun 2026