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En

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

Ref 55×15×19-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
  • 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
65×25×22-Multilayer-3D, 55×15×19-Multilayer-3D
Primary DI / UDI-DI
06978447932137, 06975367001974, 06979473601943, 06975367005262, 06978447932298, 06977979284905, 06975367002001, 06979473601950, 06977979285490, 06976029560259, 06976029560280, 06975367001981, 06975367004289, 06976459495923, 06975367001929, 06978447933011, 06978447932915, 06977979285483, 06975367001950, 06978447931567, 06977979280181, 06976029560303, 06975367001967, 06977979289139, 06979046193073, 06978447931550, 06976029560273, 06975367002018, 06976029560341
Basic UDI-DI
697844793ZCM35, B-06975367004289, B-06976459495923, B-06975367001929, B-06978447933011, B-06978447932915, B-06977979285483, B-06975367001950, B-06978447931567, B-06977979280181, B-06976029560303, B-06975367001967, B-06975367001981, B-06979473601950, B-06977979284905, B-06977979289139, B-06979046193073, B-06977979285490, B-06975367001974, B-06975367002001, B-06978447931550, B-06975367005262, B-06976029560273, B-06978447932137, B-06976029560280, B-06975367002018, B-06979473601943, B-06976029560341, B-06976029560259, B-06978447932298
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 (41)

  • EUDAMED 2af7f8cc-b5b4-4a5d-98c0-c23fbc1cbfae 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367001974|697844793ZCM35 61 fields · synced 11 Jun 2026
  • EUDAMED 06979473601943|697844793ZCM35 61 fields · synced 18 Jun 2026
  • EUDAMED 06975367005262|697844793ZCM35 61 fields · synced 19 Jun 2026
  • EUDAMED 06978447932298|697844793ZCM35 61 fields · synced 19 Jun 2026
  • EUDAMED 06977979284905|697844793ZCM35 61 fields · synced 20 Jun 2026
  • EUDAMED 06975367002001|697844793ZCM35 61 fields · synced 20 Jul 2026
  • EUDAMED 06979473601950|697844793ZCM35 61 fields · synced 24 Jul 2026
  • EUDAMED 06977979285490|697844793ZCM35 61 fields · synced 29 Jul 2026
  • EUDAMED 06976029560259|697844793ZCM35 61 fields · synced 4 Aug 2026
  • EUDAMED 06976029560280|697844793ZCM35 61 fields · synced 17 Sep 2026
  • EUDAMED 06975367001981|697844793ZCM35 61 fields · synced 6 Oct 2026
  • EUDAMED 06975367004289|B-06975367004289 61 fields · synced 7 Oct 2026
  • EUDAMED 06976459495923|B-06976459495923 61 fields · synced 7 Oct 2026
  • EUDAMED 06975367001929|B-06975367001929 61 fields · synced 7 Oct 2026
  • EUDAMED 06978447933011|B-06978447933011 61 fields · synced 8 Oct 2026
  • EUDAMED 06978447932915|B-06978447932915 61 fields · synced 11 Oct 2026
  • EUDAMED 06977979285483|B-06977979285483 61 fields · synced 12 Oct 2026
  • EUDAMED 06975367001950|B-06975367001950 61 fields · synced 13 Oct 2026
  • EUDAMED 06978447931567|B-06978447931567 61 fields · synced 14 Oct 2026
  • EUDAMED 06977979280181|B-06977979280181 61 fields · synced 18 Oct 2026
  • EUDAMED 06976029560303|B-06976029560303 61 fields · synced 20 Oct 2026
  • EUDAMED 06975367001967|B-06975367001967 61 fields · synced 20 Oct 2026
  • EUDAMED 06975367001981|B-06975367001981 61 fields · synced 24 Oct 2026
  • EUDAMED 06979473601950|B-06979473601950 61 fields · synced 24 Oct 2026
  • EUDAMED 06977979284905|B-06977979284905 61 fields · synced 24 Oct 2026
  • EUDAMED 06977979289139|B-06977979289139 61 fields · synced 24 Oct 2026
  • EUDAMED 06979046193073|B-06979046193073 61 fields · synced 24 Oct 2026
  • EUDAMED 06977979285490|B-06977979285490 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367001974|B-06975367001974 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002001|B-06975367002001 61 fields · synced 24 Oct 2026
  • EUDAMED 06978447931550|B-06978447931550 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367005262|B-06975367005262 61 fields · synced 24 Oct 2026
  • EUDAMED 06976029560273|B-06976029560273 61 fields · synced 24 Oct 2026
  • EUDAMED 06978447932137|B-06978447932137 61 fields · synced 24 Oct 2026
  • EUDAMED 06976029560280|B-06976029560280 61 fields · synced 24 Oct 2026
  • EUDAMED 06975367002018|B-06975367002018 61 fields · synced 24 Oct 2026
  • EUDAMED 06979473601943|B-06979473601943 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029560341|B-06976029560341 61 fields · synced 25 Oct 2026
  • EUDAMED 06976029560259|B-06976029560259 61 fields · synced 25 Oct 2026
  • EUDAMED 06978447932298|B-06978447932298 61 fields · synced 25 Oct 2026