Skip to content

MINI2000 Dmd Twn/Hk Ll 1 Bi -11T 0A 22

by Ormco Corporation

Ref 304-1613

Active European Union

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00889989034912 Basic UDI-DI 00889989034912UDI-DIDate1 Apr 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
304-1613
Primary DI / UDI-DI
00889989034912
Basic UDI-DI
B-00889989034912
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000038085
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Related devices

Category: Orthodontic tube

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

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