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Major.ortho - Standard Set Trs

by Major Prodotti Dentari S.p.A.

Ref C3321-TModel Self-curing orthodontic acrylic resin

Active European Union

CE MDR

Valid until

18 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

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/MDR Number8056640ORTHT Basic UDI-DI 08056640078024UDI-DIDate16 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030075-01 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    12 May 2025
    Expires
    18 Apr 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Major.ortho
Model / Reference
Self-curing orthodontic acrylic resin, C3321-T
Primary DI / UDI-DI
08056640078024
Basic UDI-DI
8056640ORTHT
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024700

Other devices from Major Prodotti Dentari S.P.A.

See all devices from Major Prodotti Dentari 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