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Biomic color opaque

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

Ref 10ml

EMDN Q01010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697758588BCOZC Basic UDI-DIDate11 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00001383 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    10 Jul 2026
    Expires
    4 Mar 2031
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
10ml
Primary DI / UDI-DI
06978447935916
Basic UDI-DI
697758588BCOZC
EMDN Code
Q01010199 Dental restoration devices - other
Device Class
Class IIa
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.

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 (1)

  • EUDAMED 06978447935916|697758588BCOZC 61 fields · synced 24 Oct 2026