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FlowTriever2 Catheter

by Inari Medical, Inc. United States EUDAMED

Ref 11-102 EMDN C019002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850291007FTSYSTEM54 Basic UDI-DIDate18 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000328595 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    2 Jul 2026
    Expires
    13 Nov 2030
    Reason
    Change approved
  • 1000332280 Restricted

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    25 Sep 2026
    Expires
    8 Nov 2028
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
11-102
Primary DI / UDI-DI
00850291007543
Basic UDI-DI
0850291007FTSYSTEM54
Direct Marketing DI
00850291007543
EMDN Code
C019002 Embolectomy catheters
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008693
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Inari Medical, Inc.

See all devices from Inari Medical, Inc. →

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 00850291007543|0850291007FTSYSTEM54 61 fields · synced 24 Oct 2026