Skip to content

C-Line

by Biocetec Co., Ltd. 52 variants

Ref CR22-1112

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-CR22-1112CT Basic UDI-DI D-CR22-1112CTUDI-DIDate8 Oct 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  • Withdrawn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

Device Name
Orthodontic Ceramic Bracket
Model / Reference
CR22-1112
Primary DI / UDI-DI
D-CR22-1112CT
Basic UDI-DI
B-CR22-1112CT
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000045343
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Biocetec Co., Ltd.

See all devices from Biocetec 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