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Orthodontic Brackets

by Hangzhou Westlake Biomaterial Co., Ltd. EUDAMED

Active European Union

Model Standard Bracket MBT 0.018"(No hook)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06951860605048 Basic UDI-DIDate9 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Orthodontic Brackets
Model / Reference
Standard Bracket MBT 0.018"(No hook)
Primary DI / UDI-DI
06951860605048
Basic UDI-DI
B-06951860605048
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000039344
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou Westlake Biomaterial Co., Ltd.

See all devices from Hangzhou Westlake Biomaterial Co., Ltd. →

Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No