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Fluoride Foam Trays

by Hubei Guarddent Medical Technology Co., Ltd EUDAMED

Active European Union

Ref Dual ArchModel Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T;Single:GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697565200FFT001ER Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T;Single:GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G, Dual Arch
Primary DI / UDI-DI
06975652007933, 06975652008251, 06975652007988
Basic UDI-DI
697565200FFT001ER
EMDN Code
Q010503 Impression material trays, single-use
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000028116
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hubei Guarddent Medical Technology Co., Ltd

See all devices from Hubei Guarddent Medical Technology Co., Ltd →

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