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Orthodontic bracket

by Zhejiang Risheng Medical Technology Co., Ltd EUDAMED

Active European Union

Ref BSR2-0133Model Ligating

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697146493BL2K Basic UDI-DIDate5 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Orthodontic bracket
Model / Reference
Ligating, BSR2-0133
Primary DI / UDI-DI
06977566455046
Basic UDI-DI
697146493BL2K
Direct Marketing DI
06977566455046
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011127
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Risheng Medical 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