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Accoat Guide Wire

by SP Medical A/S 447 variants

Ref D-S-J3-C-032-260Model Accoat Guide Wire

Expiring European Union

CE MDR

Valid until

28 Mar 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

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 Number5710086-GWACJU Basic UDI-DI 05710086020650UDI-DIDate12 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IZ 2320977-1 Expiring Supplemented Expires in 147 days

    Technical documentation EU MDR

    Certifier
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    7 Jul 2022
    Expires
    28 Mar 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
Accoat Guide Wire, D-S-J3-C-032-260
Primary DI / UDI-DI
05710086020650
Basic UDI-DI
5710086-GWACJU
EMDN Code
C04010202 Coronary artery therapeutic guidewires, non-hydrophilic
Device Class
Class III
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000019782

Other devices from SP Medical A/S

See all devices from SP Medical A/S →

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