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Name: Spinnaker Model: Direct Bonding Stainless Steel Orthodontic buccal tubes

by Micerium S.p.A. 108 variants

Ref TSSE2K7MModel Direct buccal tubes

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++EMICFAM3C4DD5K Basic UDI-DI EMICTSSE2K7M1UDI-DIDate27 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Name: Spinnaker Model: Direct Bonding Stainless Steel Orthodontic buccal tubes
Model / Reference
Direct buccal tubes, TSSE2K7M
Primary DI / UDI-DI
EMICTSSE2K7M1
Basic UDI-DI
++EMICFAM3C4DD5K
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010187

Other devices from Micerium S.p.A.

See all devices from Micerium S.p.A. →

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