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En

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

Ref 98×16-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  • Withdrawn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, 98×16-COLOR
Primary DI / UDI-DI
06977585889563, 06975347283086, 06975347283000, 06976029562970, 06975347283031, 06975347283093, 06975347285820, 06975347285851, 06975347285844, 06976029563045, 06975347285806, 06976029562925, 06975347285868, 06976029562932, 06976029562987, 06975347285943, 06975347285912, 06975347283062, 06977585889594, 06976029563021, 06975347285790, 06977585889570, 06975347283055, 06975347283017, 06975347283079, 06975347282966, 06975347285905, 06975347285882, 06975347282959, 06976029562949, 06975347283024, 06976029563014
Basic UDI-DI
697645949ZCCZW, B-06977585889594, B-06976029563021, B-06975347285790, B-06977585889570, B-06975347283055, B-06975347283062, B-06975347283017, B-06975347283079, B-06975347282966, B-06975347283031, B-06976029562932, B-06975347285851, B-06975347285905, B-06975347285882, B-06975347285844, B-06975347282959, B-06976029563045, B-06975347283086, B-06976029562970, B-06975347285806, B-06976029562949, B-06975347285820, B-06975347285912, B-06975347285868, B-06975347283000, B-06976029562987, B-06975347283024, B-06975347285943, B-06976029562925, B-06976029563014, B-06975347283093, B-06977585889563
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.

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

  • En

    Class IIa

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 (50)

  • EUDAMED 71acdc5d-d5a1-4894-9527-96222e736a1d 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347283086|697645949ZCCZW 61 fields · synced 18 Jun 2026
  • EUDAMED 06975347283000|697645949ZCCZW 61 fields · synced 18 Jun 2026
  • EUDAMED 06976029562970|697645949ZCCZW 61 fields · synced 19 Jun 2026
  • EUDAMED 06975347283031|697645949ZCCZW 61 fields · synced 9 Jul 2026
  • EUDAMED 06975347283093|697645949ZCCZW 61 fields · synced 10 Jul 2026
  • EUDAMED 06975347285820|697645949ZCCZW 61 fields · synced 10 Jul 2026
  • EUDAMED 06975347285851|697645949ZCCZW 61 fields · synced 10 Jul 2026
  • EUDAMED 06975347285844|697645949ZCCZW 61 fields · synced 10 Jul 2026
  • EUDAMED 06976029563045|697645949ZCCZW 61 fields · synced 16 Jul 2026
  • EUDAMED 06975347285806|697645949ZCCZW 61 fields · synced 17 Jul 2026
  • EUDAMED 06976029562925|697645949ZCCZW 61 fields · synced 19 Jul 2026
  • EUDAMED 06975347285868|697645949ZCCZW 61 fields · synced 20 Jul 2026
  • EUDAMED 06976029562932|697645949ZCCZW 61 fields · synced 21 Jul 2026
  • EUDAMED 06976029562987|697645949ZCCZW 61 fields · synced 23 Jul 2026
  • EUDAMED 06975347285943|697645949ZCCZW 61 fields · synced 24 Jul 2026
  • EUDAMED 06975347285912|697645949ZCCZW 61 fields · synced 29 Jul 2026
  • EUDAMED 06975347283062|697645949ZCCZW 61 fields · synced 1 Oct 2026
  • EUDAMED 06977585889594|B-06977585889594 61 fields · synced 7 Oct 2026
  • EUDAMED 06976029563021|B-06976029563021 61 fields · synced 13 Oct 2026
  • EUDAMED 06975347285790|B-06975347285790 61 fields · synced 16 Oct 2026
  • EUDAMED 06977585889570|B-06977585889570 61 fields · synced 17 Oct 2026
  • EUDAMED 06975347283055|B-06975347283055 61 fields · synced 17 Oct 2026
  • EUDAMED 06975347283062|B-06975347283062 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347283017|B-06975347283017 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347283079|B-06975347283079 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347282966|B-06975347282966 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347283031|B-06975347283031 61 fields · synced 24 Oct 2026
  • EUDAMED 06976029562932|B-06976029562932 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285851|B-06975347285851 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285905|B-06975347285905 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285882|B-06975347285882 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347285844|B-06975347285844 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347282959|B-06975347282959 61 fields · synced 24 Oct 2026
  • EUDAMED 06976029563045|B-06976029563045 61 fields · synced 24 Oct 2026
  • EUDAMED 06975347283086|B-06975347283086 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029562970|B-06976029562970 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347285806|B-06975347285806 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029562949|B-06976029562949 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347285820|B-06975347285820 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347285912|B-06975347285912 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347285868|B-06975347285868 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347283000|B-06975347283000 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029562987|B-06976029562987 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347283024|B-06975347283024 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347285943|B-06975347285943 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029562925|B-06976029562925 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029563014|B-06976029563014 61 fields · synced 25 Oct 2026
  • EUDAMED 06975347283093|B-06975347283093 61 fields · synced 25 Oct 2026
  • EUDAMED 06977585889563|B-06977585889563 61 fields · synced 25 Oct 2026