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Blood pump

by Berlin Heart GmbH 5 variants

Ref P80C-001

Active European Union

CE MDR

Valid until

9 Jan 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service 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 Number4260090042465QW Basic UDI-DI 04260090040676UDI-DIDate24 Apr 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Blood pump
Model / Reference
P80C-001
Primary DI / UDI-DI
04260090040676
Basic UDI-DI
4260090042465QW
EMDN Code
C03010101 Extracorporeal circulation circuits
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006521

Other devices from Berlin Heart GmbH

See all devices from Berlin Heart GmbH →

Properties

  • Sterile
  • Animal Tissues
  • Incorporates Medicinal Product

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No