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En

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

Ref 65×40×22-COLORModel COLOR, STC, SHTPC, SHT-Plus EMDN Q01010101

Regulatory status

as of 25 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
  • 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  • Withdrawn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
COLOR, STC, SHTPC, SHT-Plus, 65×40×22-COLOR
Primary DI / UDI-DI
06975347285424, 06975347282423, 06975347282416, 06975347282386, 06975347285394, 06975347285417, 06975347282362, 06975347285400, 06975347282393, 06975347282379
Basic UDI-DI
697645949ZCCZW, B-06975347282393, B-06975347282379, B-06975347282386, B-06975347285417, B-06975347285424, B-06975347285394, B-06975347282416, B-06975347282362, B-06975347285400, B-06975347282423
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 (18)

  • EUDAMED c64a5ac7-3936-430a-b3ef-117116745eee 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347282423|697645949ZCCZW 61 fields · synced 18 Jun 2026
  • EUDAMED 06975347282416|697645949ZCCZW 61 fields · synced 19 Jun 2026
  • EUDAMED 06975347282386|697645949ZCCZW 61 fields · synced 10 Jul 2026
  • EUDAMED 06975347285394|697645949ZCCZW 61 fields · synced 20 Jul 2026
  • EUDAMED 06975347285417|697645949ZCCZW 61 fields · synced 22 Jul 2026
  • EUDAMED 06975347282362|697645949ZCCZW 61 fields · synced 2 Aug 2026
  • EUDAMED 06975347285400|697645949ZCCZW 61 fields · synced 18 Sep 2026
  • EUDAMED 06975347282393|B-06975347282393 61 fields · synced 9 Oct 2026
  • EUDAMED 06975347282379|B-06975347282379 61 fields · synced 13 Oct 2026
  • EUDAMED 06975347282386|B-06975347282386 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285417|B-06975347285417 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285424|B-06975347285424 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285394|B-06975347285394 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347282416|B-06975347282416 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347282362|B-06975347282362 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285400|B-06975347285400 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347282423|B-06975347282423 61 fields · synced 25 Oct 2026