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En

by Aidite（Qinhuangdao）Technology Co., Ltd. China EUDAMED

Ref 95×22-Multilayer-3DModel 65×25×22-Multilayer-3D

EMDN Q01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697844793ZCM35 Basic UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDR Number697844793ZCM35 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
En
Dental Zirconia Ceramic
Model / Reference
65×25×22-Multilayer-3D, 95×22-Multilayer-3D
Primary DI / UDI-DI
06975367004845, 06975367002728, 06975367002759, 06976029561034, 06976029561027, 06975367002742, 06975367002735, 06978447934674
Basic UDI-DI
697844793ZCM35, B-06975367002759, B-06976029561034, B-06976029561027, B-06975367002742, B-06975367002735, B-06975367004845, B-06975367002728, B-06978447934674
EMDN Code
Q01010101, Q01010199
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015573
Authorised representative
AIDITE Europe GmbH DE-AR-000048785

Other devices from Aidite (Qinhuangdao) Technology Co., Ltd

See all devices from Aidite (Qinhuangdao) Technology Co., Ltd →

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 (10)

  • EUDAMED 6099a9f4-7547-427b-9673-3d4552546e81 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002728|697844793ZCM35 61 fields · synced 18 Jun 2026
  • EUDAMED 06975367002759|B-06975367002759 61 fields · synced 8 Oct 2026
  • EUDAMED 06976029561034|B-06976029561034 61 fields · synced 11 Oct 2026
  • EUDAMED 06976029561027|B-06976029561027 61 fields · synced 12 Oct 2026
  • EUDAMED 06975367002742|B-06975367002742 61 fields · synced 15 Oct 2026
  • EUDAMED 06975367002735|B-06975367002735 61 fields · synced 19 Oct 2026
  • EUDAMED 06975367004845|B-06975367004845 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002728|B-06975367002728 61 fields · synced 24 Oct 2026
  • EUDAMED 06978447934674|B-06978447934674 61 fields · synced 24 Oct 2026