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Empower Tube

by American Orthodontics 292 variants

Ref 0082-22-4625H, 008-18-2614H, 963-22-4625HMCC, 9552-22-4620H, 961-22-1610HMCC, 9642-18-3620HM, 956-18-3614HCC, 964-22-3614HMCC, 0082-18-4620H, 958-18-2614HCC, 964-18-3620HMCC, 963-22-4610HM, 962-18-2610HMCC, 961-18-1610HM, 958-22-260H, 955-18-4628H, 964-22-3620HM, 961-18-1614HM, 964-18-3610HMCC, 9562-18-3625H, 961-22-160HM, 008-18-4614H, 964-18-3614HMCC, 956-18-360HCC, 956-22-3610H, 957-18-1610H, 955-22-4620HCC, 962-22-2618HMCC, 958-18-260HCC, 9582-22-2614HCC, 955-18-4610H, 964-18-3614HM, 962-22-2610HM, 962-22-260HM, 9622-22-2610HM, 9642-22-3620HMCC, 0082-22-3628H, 9632-18-4620HMCC, 008-22-4610H, 9562-18-3620H, 962-18-2614HM, 964-22-3620HMYCC, 008-22-2618H, 008-18-3625H, 958-22-2610HCC, 963-18-4610HMCC, 963-18-4614HMCC, 008-22-4625H, 961-22-1618HM, 9632-22-4620HM, 9622-22-2614HMCC

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01907460000126DR Basic UDI-DI Date31 Jul 2025RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
0082-22-4625H, 008-18-2614H, 963-22-4625HMCC, 9552-22-4620H, 961-22-1610HMCC, 9642-18-3620HM, 956-18-3614HCC, 964-22-3614HMCC, 0082-18-4620H, 958-18-2614HCC, 964-18-3620HMCC, 963-22-4610HM, 962-18-2610HMCC, 961-18-1610HM, 958-22-260H, 955-18-4628H, 964-22-3620HM, 961-18-1614HM, 964-18-3610HMCC, 9562-18-3625H, 961-22-160HM, 008-18-4614H, 964-18-3614HMCC, 956-18-360HCC, 956-22-3610H, 957-18-1610H, 955-22-4620HCC, 962-22-2618HMCC, 958-18-260HCC, 9582-22-2614HCC, 955-18-4610H, 964-18-3614HM, 962-22-2610HM, 962-22-260HM, 9622-22-2610HM, 9642-22-3620HMCC, 0082-22-3628H, 9632-18-4620HMCC, 008-22-4610H, 9562-18-3620H, 962-18-2614HM, 964-22-3620HMYCC, 008-22-2618H, 008-18-3625H, 958-22-2610HCC, 963-18-4610HMCC, 963-18-4614HMCC, 008-22-4625H, 961-22-1618HM, 9632-22-4620HM, 9622-22-2614HMCC
Primary DI / UDI-DI
00190746201417, 00190746201059, 00190746198267, 00190746202186, 00190746198113, 00190746201967, 00190746197284, 00190746197840, 00190746201141, 00190746198052, 00190746198281, 00190746201776, 00190746197628, 00190746201509, 00190746202704, 00190746202117, 00190746201936, 00190746201516, 00190746197741, 00190746202353, 00190746201530, 00190746201455, 00190746197765, 00190746197260, 00190746202438, 00190746202490, 00190746197901, 00190746198205, 00190746197499, 00190746197543, 00190746202063, 00190746201875, 00190746201653, 00190746201646, 00190746201707, 00190746198311, 00190746201479, 00190746198236, 00190746201295, 00190746030123, 00190746201622, 00190746197857, 00190746201219, 00190746201073, 00190746198076, 00190746197673, 00190746197680, 00190746201325, 00190746201561, 00190746201844, 00190746198175
Basic UDI-DI
01907460000126DR
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007702
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Related devices

Category: Orthodontic tube

Other devices from American Orthodontics

See all devices from American Orthodontics →

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