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Galaxy Fixation System

by Orthofix Srl 23 variants

Ref T939300Model BONE FIXATION SYSTEMS, EXTERNAL

Galaxy Fixation System (T939300) is a Class I device made by Orthofix SRL, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 805050436ExFix1NACDB), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805050436ExFix1NACDB Basic UDI-DI 18053504361046UDI-DIDate2 Nov 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
BONE FIXATION SYSTEMS, EXTERNAL, T939300
Primary DI / UDI-DI
18053504361046
Basic UDI-DI
805050436ExFix1NACDB
EMDN code
P0912040102 Axial bone fixation systems
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000015631

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Orthofix SRL

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Properties

  • Sterilise before use
Other properties (13, all answered No)