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Synthetic Polymer Teeth

by Shandong Huge Dental Material Corporation FDA registration: China EUDAMED

Ref Prime/32ML/A3.5/8×1Model Upper anterior teeth, Lower anterior teeth, Posterior teeth EMDN Q01020601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6909412RZY2A019J Basic UDI-DIDate3 Jun 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
Upper anterior teeth, Lower anterior teeth, Posterior teeth, Prime/32ML/A3.5/8×1
Primary DI / UDI-DI
06909412194816
Basic UDI-DI
6909412RZY2A019J
EMDN Code
Q01020601 Mobile dental prostheses
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000013266
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

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 (1)

  • EUDAMED 06909412194816|6909412RZY2A019J 61 fields · synced 25 Oct 2026