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Helix

by SWL Medizin GmbH Germany EUDAMED

Ref MDS832000Model MDS 3D

EMDN Z12109001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42517902MDS3DG2 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1TD-MDR-0065/06/2026/02 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2764
    Issued
    5 Jun 2026
    Expires
    4 Jun 2029

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Detachable Coil System
Model / Reference
MDS 3D, MDS832000
Primary DI / UDI-DI
04251790220000
Basic UDI-DI
42517902MDS3DG2
EMDN Code
Z12109001 Detachable coil equipment for brain aneurysms
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
DE-MF-000008000

Other devices from SWL Medizin GmbH

See all devices from SWL Medizin GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 04251790220000|42517902MDS3DG2 61 fields · synced 24 Oct 2026