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Helix

by SWL Medizin GmbH 241 variants

Ref MDS831791Model MDS 10

Active European Union

CE MDR

Valid until

4 Jun 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

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 Number1TD-MDR-0065/06/2026/02 Date5 Jun 2026IssuedStatusActive expires 4 Jun 2029

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

    Certifier
    Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi 2764
    Issued
    5 Jun 2026
    Expires
    4 Jun 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Detachable Coil System
Model / Reference
MDS 10, MDS831791
Primary DI / UDI-DI
04251790217918
Basic UDI-DI
42517902MDS10EN
EMDN Code
Z12109001 Detachable coil equipment for brain aneurysms
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
DE-MF-000008000

Other devices from SWL Medizin GmbH

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See all devices from SWL Medizin GmbH →

Properties

  • 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