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Exact

by Astar Orthodontics Inc. United States EUDAMED

Ref 1651-042

EMDN Q010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69416735OCB735LJ Basic UDI-DIDate15 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Orthodontic Ceramic Brackets
Model / Reference
1651-042
Primary DI / UDI-DI
06941673523820
Basic UDI-DI
69416735OCB735LJ
Direct Marketing DI
06941673523820
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000028647
Authorised representative
BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480

Other devices from Astar Orthodontics Inc.

See all devices from Astar Orthodontics Inc. →

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 06941673523820|69416735OCB735LJ 61 fields · synced 24 Oct 2026