Skip to content

Unique

by SWL Medizin GmbH 8 variants

Ref PGW826704

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-04251790267043 Basic UDI-DI 04251790267043UDI-DIDate6 May 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  • Withdrawn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
PTCA Guidewire
Model / Reference
PGW826704
Primary DI / UDI-DI
04251790267043
Basic UDI-DI
B-04251790267043
EMDN Code
C04010101 Coronary artery diagnostic guidewires, hydrophilic
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 (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No