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Kit composed of an External Cardiac Pacemaker model 4427 + threshold cable model F7830S.

by FIAB S.p.A. 2 variants

Ref 80442700-60515760

Active European Union

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803300326005000009LW Basic UDI-DI 28054751932680UDI-DIDate23 Sep 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Kit composed of an External Cardiac Pacemaker model 4427 + threshold cable model F7830S.
Model / Reference
80442700-60515760
Primary DI / UDI-DI
28054751932680
Basic UDI-DI
803300326005000009LW
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIb
Medical Purpose
In the context of a temporary cardiac stimulation: the external cardiac pacemaker is intended for temporary single-chamber stimulation either synchronous or asynchronous short term for therapeutic, prophylactic or diagnostic purposes; cable intended for connection between an external device and a temporary cardiac lead

Manufacturer details

EUDAMED SRN
IT-PR-000048498

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See all devices from FIAB S.p.A. →

Properties

Other properties (1)

  • Sterile: No