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Kit - ORTRAUTEK IORTH-MI

by Global D EUDAMED

Active European Union

Ref BP-PR-IORTH-MI-SS

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3662601PACK22012aa7E Basic UDI-DIDate6 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Kit - ORTRAUTEK IORTH-MI
Model / Reference
BP-PR-IORTH-MI-SS
Primary DI / UDI-DI
03662601075428
Basic UDI-DI
3662601PACK22012aa7E
EMDN Code
L031308,L091001,L091002,L091099,L150702,P09120599,P09120699,S010301,S0199,V901699,Z12119099
Device Class
Class IIb
Medical Purpose
The IORTH-MI Kit is indicated for stabilisation and cranio maxillofacial bone fixation during osteosynthesis and the bone consolidation period in the following situations: • orthognathic surgery, • traumatology surgery, • reconstructive surgery.

Manufacturer details

EUDAMED SRN
FR-PR-000024268

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Properties

Other properties (1)

  • Sterile: No