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En

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

Ref 98×12-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
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
En
Dental Zirconia Ceramic
Model / Reference
65×25×22-Multilayer-3D, 98×12-Multilayer-3D
Primary DI / UDI-DI
06970469233131
Basic UDI-DI
697844793ZCM35, B-06970469233131
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 (2)

  • EUDAMED 3bc14a81-6044-4bad-928f-e673306c0fcd 61 fields · synced 22 Oct 2026
  • EUDAMED 06970469233131|B-06970469233131 61 fields · synced 11 Oct 2026