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Intra-aortic balloon catheter set

by Balton Sp. z o.o. 23 variants

Ref IABC8F34

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-05901297127850 Basic UDI-DI Date9 Oct 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

Poland
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

  • Poland

Specification

EUDAMED

Device Name
Intra-aortic balloon catheter set
Model / Reference
IABC8F34
Primary DI / UDI-DI
05901297127850, 05901297398786, 05901297153644, 05901297134070
Basic UDI-DI
B-05901297127850, B-05901297398786, B-05901297153644, B-05901297134070
EMDN Code
C019001 Aortic counterpulsation catheters
Device Class
Class III
EU market of registration
Poland
Portugal
Spain
Italy

Manufacturer details

EUDAMED SRN
PL-MF-000010568

Other devices from Balton Sp. z o.o.

See all devices from Balton Sp. z o.o. →

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