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Nitinol (NiTi) Orthodontic Wires

by Beijing Smart Technology Co., Ltd. 116 variants

Ref SE-D-20-L

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06941784100149 Basic UDI-DI 06941784100149UDI-DIDate27 Mar 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06941784100149 Basic UDI-DI 06941784100149UDI-DIDate27 Mar 2024RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
NiTi Orthodontic Wire
Model / Reference
SE-D-20-L
Primary DI / UDI-DI
06941784100149
Basic UDI-DI
B-06941784100149, 69417841NTWIRE56
EMDN Code
Q010405 Orthodontic wires
Device Class
Class IIa
EU market of registration
Italy
France

Manufacturer details

EUDAMED SRN
CN-MF-000015988
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Beijing Smart Technology Co., Ltd

See all devices from Beijing Smart Technology Co., Ltd →

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