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Halo One Thin Walled Guiding Sheath

by ClearStream Technologies Ltd 40 variants

Ref HLO61035F

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-0080174116196LCZ Basic UDI-DI D-0080174116196LCZUDI-DIDate19 Oct 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Halo One Thin Walled Guiding Sheath
Model / Reference
HLO61035F
Primary DI / UDI-DI
D-0080174116196LCZ
Basic UDI-DI
B-0080174116196LCZ
EMDN Code
C0104010202 Cardiac angiography guide catheters
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IE-MF-000011725

Other devices from Clearstream Technologies Ltd.

See all devices from Clearstream Technologies Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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