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FLOWer

by AORTICLAB s.r.l. 3 variants

Ref PF-TAF-032Model FLOWer

Active European Union

CE MDR

Valid until

21 Dec 2028

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 NumberG70 110786 0002 Date22 Jun 2026IssuedStatusActive expires 21 Dec 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 110786 0002 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    22 Jun 2026
    Expires
    21 Dec 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
FLOWer Transcatheter Antiembolic Filter
Model / Reference
FLOWer, PF-TAF-032
Primary DI / UDI-DI
08057500100329
Basic UDI-DI
805750010FLOWER9S
EMDN Code
C01050299 Intravascular embolic protection catheters and systems - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026729

Other devices from AORTICLAB s.r.l.

  • FLOWer

    Class III

  • FLOWer

    Class III

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