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Resin-based dental luting cement

by Aidite（Qinhuangdao）Technology Co., Ltd. 6 variants

Ref ACDC08A3Model TR-8g

Active European Union

CE MDR

Valid until

4 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697758588DLCZR Basic UDI-DI 06977585882946UDI-DIDate24 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00001383 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    10 Jul 2026
    Expires
    4 Mar 2031
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
TR-8g, ACDC08A3
Primary DI / UDI-DI
06977585882946
Basic UDI-DI
697758588DLCZR
EMDN Code
Q0101010201 Dental base cements
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015573
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Aidite (Qinhuangdao) Technology Co., Ltd.

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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