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52050WTINP

by FIAB S.p.A.

Ref 52050WTINPModel MYOPACE epimyocardial pacing wires for temporary cardiac stimulation

Active European Union

CE MDR

Valid until

26 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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/MDR NumberMDR 747885 Date23 Jul 2026IssuedStatusActive expires 26 Mar 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 747885 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    23 Jul 2026
    Expires
    26 Mar 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
MYOPACE epimyocardial pacing wires for temporary cardiac stimulation, 52050WTINP
Primary DI / UDI-DI
08054242445596
Basic UDI-DI
803300326011000003JZ
EMDN Code
C020202 Epicardial leads (monopolar and bipolar)
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005988

Other devices from FIAB S.p.A.

See all devices from FIAB S.p.A. →

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