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Orthodontic Brackets

by Hangzhou DTC Medical Apparatus Co., Ltd China EUDAMED

Ref ORT-C22-4031

EMDN Q010403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69419855DTCTC1000133 Basic UDI-DIDate29 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

IcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

EU market availability

Available in 32 countries, as listed in EUDAMED:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Last checked 25 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
ORT-C22-4031
Primary DI / UDI-DI
06941985547378
Basic UDI-DI
69419855DTCTC1000133
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000032021
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou DTC Medical Apparatus Co., Ltd

See all devices from Hangzhou DTC Medical Apparatus 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 06941985547378|69419855DTCTC1000133 61 fields · synced 25 Oct 2026