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En

by Aidite（Qinhuangdao）Technology Co., Ltd. 1,000+ variants

Ref 95×12-SHT-PlusModel COLOR, STC, SHTPC, SHT-Plus

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697645949ZCCZW Basic UDI-DI Date28 May 2026RegisteredStatusActive
European UnionCE/MDR Number697645949ZCCZW Basic UDI-DI Date28 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
En
Dental Zirconia Ceramic
Model / Reference
COLOR, STC, SHTPC, SHT-Plus, 95×12-SHT-Plus
Primary DI / UDI-DI
06975347289453, 06978447936456, 06978447936432, 06975347289446, 06977132545508, 06979046193684, 06977979285247, 06976459490041, 06979046197453, 06976029568842, 06977132545287, 06977585889433, 06975347289439, 06976459490713, 06976459491338, 06976459491536, 06977979285292, 06975784828192, 06975347289422, 06975347289477, 06977979285308, 06976459490065, 06976459491444, 06979473609475, 06977132545515, 06977585883530, 06979473609079, 06976459491543, 06975347289460
Basic UDI-DI
697645949ZCCZW, B-06975784828192, B-06975347289422, B-06975347289477, B-06977979285308, B-06976459490065, B-06976459491444, B-06979473609475, B-06977132545515, B-06979046197453, B-06975347289446, B-06977979285292, B-06977585883530, B-06979473609079, B-06977132545287, B-06976459491536, B-06978447936432, B-06977132545508, B-06976459490713, B-06979046193684, B-06975347289453, B-06976029568842, B-06976459491543, B-06975347289439, B-06977585889433, B-06977979285247, B-06976459490041, B-06975347289460, B-06978447936456, B-06976459491338
EMDN Code
Q01010101, Q01010199
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015573
Authorised representative
AIDITE Europe GmbH DE-AR-000048785

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Properties

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