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52220BTL

by FIAB S.p.A. Italy EUDAMED

Ref 52220BTLModel MYOPACE epimyocardial pacing wires for temporary cardiac stimulation

EMDN C020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803300326011000003JZ Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 747885 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    23 Jul 2026
    Expires
    26 Mar 2030
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MYOPACE epimyocardial pacing wires for temporary cardiac stimulation, 52220BTL
Primary DI / UDI-DI
08054242445190
Basic UDI-DI
803300326011000003JZ
EMDN Code
C020202 Epicardial leads (monopolar and bipolar)
Device Class
Class III
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08054242445190|803300326011000003JZ 61 fields · synced 24 Oct 2026