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En

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

Ref 95×14-SHT-PlusModel COLOR, STC, SHTPC, SHT-Plus

EMDN Q01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697645949ZCCZW Basic UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDR Number697645949ZCCZW 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 22 Oct 2026

Trade Name
En
Dental Zirconia Ceramic
Model / Reference
COLOR, STC, SHTPC, SHT-Plus, 95×14-SHT-Plus
Primary DI / UDI-DI
06978447936463
Basic UDI-DI
697645949ZCCZW, B-06978447936463
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 81c5f8fe-1457-456e-829f-e1bc6ae68cff 61 fields · synced 22 Oct 2026
  • EUDAMED 06978447936463|B-06978447936463 61 fields · synced 7 Oct 2026