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SDX System and Medikro syringe

by Dyn'r

Ref SDX0306V3.0_M9474-D

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376029023SDX0306M9474LJW3 Basic UDI-DI 03760290230040UDI-DIDate15 Jan 2024RegisteredStatusActive

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  • Withdrawn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
SDX System and Medikro syringe
Model / Reference
SDX0306V3.0_M9474-D
Primary DI / UDI-DI
03760290230040
Basic UDI-DI
376029023SDX0306M9474LJW3
EMDN Code
Z11019099 Various radiotherapy and radiosurgery instruments - other
Device Class
Class IIb
Medical Purpose
The SDX System is intended for use in Radiation Therapy as an aid in allowing the patient and treatment staff to visualize a patient breathing process and to optimize breathing to limit internal motion during imaging & treatment. The SDX System with the Gating Module interface is used to provide respiratory synchronization for both radiation therapy imaging equipment and for radiation treatment equipment (photon & proton particle systems). Indication : Population with thoracoabdominal cancer undergoing radiotherapy and capable of understanding and following the instructions of radiotherapists.

Manufacturer details

EUDAMED SRN
FR-PR-000023844

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Properties

Other properties (1)

  • Sterile: No