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FlexCath Cross™

by Medtronic, Inc. United States EUDAMED

Ref 900305

EMDN C01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0763000B00028488Y Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000225868 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    9 Jun 2026
    Expires
    8 Jun 2031
  • 1000277712 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    9 Jun 2026
    Expires
    8 Jun 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
FlexCath Cross Transseptal Needle
Model / Reference
900305
Primary DI / UDI-DI
00763000941765
Basic UDI-DI
0763000B00028488Y
EMDN Code
C01020101 Central i.v. single-lumen catheters, peripheral access
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019977
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic, Inc.

See all devices from Medtronic, 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 00763000941765|0763000B00028488Y 61 fields · synced 24 Oct 2026