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En

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

Ref 40×15×14-Multilayer-3DModel 65×25×22-Multilayer-3D EMDN Q01010101

Regulatory status

as of 25 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
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Trade Name
En
Dental Zirconia Ceramic
Model / Reference
65×25×22-Multilayer-3D, 40×15×14-Multilayer-3D
Primary DI / UDI-DI
06976459492441, 06975367008522, 06975784824163, 06975367001752, 06975367001745, 06975367008287, 06975367001769, 06975367008478, 06975367008546
Basic UDI-DI
697844793ZCM35, B-06975367008287, B-06975367001769, B-06975367001745, B-06975367008522, B-06975367008478, B-06975784824163, B-06975367008546, B-06975367001752, B-06976459492441
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.

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

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 (14)

  • EUDAMED cc41368a-8b58-472f-ad10-99f75f607ec4 61 fields · synced 25 Oct 2026
  • EUDAMED 06975367008522|697844793ZCM35 61 fields · synced 18 Jun 2026
  • EUDAMED 06975784824163|697844793ZCM35 61 fields · synced 10 Jul 2026
  • EUDAMED 06975367001752|697844793ZCM35 61 fields · synced 15 Jul 2026
  • EUDAMED 06975367001745|697844793ZCM35 61 fields · synced 16 Jul 2026
  • EUDAMED 06975367008287|B-06975367008287 61 fields · synced 9 Oct 2026
  • EUDAMED 06975367001769|B-06975367001769 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367001745|B-06975367001745 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367008522|B-06975367008522 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367008478|B-06975367008478 61 fields · synced 24 Oct 2026
  • EUDAMED 06975784824163|B-06975784824163 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367008546|B-06975367008546 61 fields · synced 25 Oct 2026
  • EUDAMED 06975367001752|B-06975367001752 61 fields · synced 25 Oct 2026
  • EUDAMED 06976459492441|B-06976459492441 61 fields · synced 25 Oct 2026