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Litepac

by ClearStream Technologies Ltd 77 variants

Ref 68202105

Expiring European Union

CE MDR

Valid until

1 Jan 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539150983XQCKAZYWKC Basic UDI-DI 05391509838511UDI-DIDate13 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2249575CE03 Expiring Supplemented Expires in 61 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Jan 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
LitePAC™ Rapid Exchange PTA Balloon Catheter with SiLX2™ coating
Model / Reference
68202105
Primary DI / UDI-DI
05391509838511
Basic UDI-DI
539150983XQCKAZYWKC
EMDN Code
C010402020101 PTA balloon dilatation 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