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Calbreak

by SWL Medizin GmbH 13 variants

Ref 835523

Active European Union

CE MDR

Valid until

11 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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 Number42517902VBCVE Basic UDI-DI 04251790255231UDI-DIDate16 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0008 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    12 Mar 2026
    Expires
    11 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Coronary Cutting Balloon Dilatation Catheter
Model / Reference
835523
Primary DI / UDI-DI
04251790255231
Basic UDI-DI
42517902VBCVE
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
DE-MF-000008000

Other devices from SWL Medizin GmbH

  • Helix

    Class III

  • Mercury

    Class IIa

  • SWL-Pioneer

    Class III

  • NC Osier™

    Class III

  • Helix

    Class III

  • Helix

    Class III

See all devices from SWL Medizin GmbH →

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