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En

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

Ref 98×22-COLORModel 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, 98×22-COLOR
Primary DI / UDI-DI
06975347286315
Basic UDI-DI
697645949ZCCZW, B-06975347286315
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

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 f6b17241-f06c-424a-9293-eebb54dc4766 61 fields · synced 22 Oct 2026
  • EUDAMED 06975347286315|B-06975347286315 61 fields · synced 12 Oct 2026