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En

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

Ref 95×12-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
  • 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, 95×12-Multilayer-3D
Primary DI / UDI-DI
06976087537873, 06978447931277, 06975367002353, 06976029564493, 06976029564431, 06975367002308, 06975367002360, 06976029564486, 06978447932069, 06978447932052, 06976029564448, 06975367004838, 06975367002384, 06975367002315
Basic UDI-DI
697844793ZCM35, B-06978447932069, B-06978447932052, B-06976029564448, B-06976029564493, B-06975367004838, B-06975367002384, B-06978447931277, B-06976087537873, B-06975367002315, B-06976029564486, B-06975367002353, B-06975367002360, B-06975367002308, B-06976029564431
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 (22)

  • EUDAMED 58ffc1e5-2efb-42dd-b058-7f6160a356c6 61 fields · synced 24 Oct 2026
  • EUDAMED 06978447931277|697844793ZCM35 61 fields · synced 18 Jun 2026
  • EUDAMED 06975367002353|697844793ZCM35 61 fields · synced 19 Jun 2026
  • EUDAMED 06976029564493|697844793ZCM35 61 fields · synced 17 Jul 2026
  • EUDAMED 06976029564431|697844793ZCM35 61 fields · synced 18 Jul 2026
  • EUDAMED 06975367002308|697844793ZCM35 61 fields · synced 23 Jul 2026
  • EUDAMED 06975367002360|697844793ZCM35 61 fields · synced 25 Jul 2026
  • EUDAMED 06976029564486|697844793ZCM35 61 fields · synced 29 Jul 2026
  • EUDAMED 06978447932069|B-06978447932069 61 fields · synced 9 Oct 2026
  • EUDAMED 06978447932052|B-06978447932052 61 fields · synced 11 Oct 2026
  • EUDAMED 06976029564448|B-06976029564448 61 fields · synced 13 Oct 2026
  • EUDAMED 06976029564493|B-06976029564493 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367004838|B-06975367004838 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002384|B-06975367002384 61 fields · synced 24 Oct 2026
  • EUDAMED 06978447931277|B-06978447931277 61 fields · synced 24 Oct 2026
  • EUDAMED 06976087537873|B-06976087537873 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002315|B-06975367002315 61 fields · synced 24 Oct 2026
  • EUDAMED 06976029564486|B-06976029564486 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002353|B-06975367002353 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002360|B-06975367002360 61 fields · synced 25 Oct 2026
  • EUDAMED 06975367002308|B-06975367002308 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029564431|B-06976029564431 61 fields · synced 25 Oct 2026