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Metal Brackets

by Innovative Material and Devices, Inc China EUDAMED

Ref KIT16-221-00CHKModel None self-ligating Brackets

EMDN Q010403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695706706001-7000K4 Basic UDI-DIDate26 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
None self-ligating Brackets, KIT16-221-00CHK
Primary DI / UDI-DI
06937382860202
Basic UDI-DI
695706706001-7000K4
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000002280
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Innovative Material and Devices, Inc

See all devices from Innovative Material and Devices, 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 06937382860202|695706706001-7000K4 61 fields · synced 24 Oct 2026