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FlexCath Cross Transseptal Solution

by Acutus Medical, Inc. United States EUDAMED

Ref 900309

EMDN C01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850027837ACQCROSSP3 Basic UDI-DIDate8 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000166386 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    22 Feb 2024
    Expires
    21 Feb 2029
  • 1000165613 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    22 Feb 2024
    Expires
    14 Nov 2027

Specification

EUDAMED · synced 22 Oct 2026

Device Name
AcQCross Qx Integrated Transseptal Dilator/Needle
Model / Reference
900309
Primary DI / UDI-DI
00850027837932
Basic UDI-DI
0850027837ACQCROSSP3
EMDN Code
C01020101 Central i.v. single-lumen catheters, peripheral access
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000019413
Authorised representative
MDSS GmbH DE-AR-000005430

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 b738e719-54e6-4650-a203-1de4e91df0aa 61 fields · synced 22 Oct 2026