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Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 5 Fr. Catheters

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Ref DE-09600-UNH

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08019020000000000000103K3 Basic UDI-DI 10801902194432UDI-DIDate19 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Multi-Lumen Access Catheter (MAC) & Percutaneous Sheath Introducer (PSI) Product
Model / Reference
DE-09600-UNH
Primary DI / UDI-DI
10801902194432
Basic UDI-DI
08019020000000000000103K3, 08019020000000000000121K5
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIb
EU market of registration
Ireland
Medical Purpose
The Arrow Multi-Lumen Central Venous Access Device permits venous access for procedures requiring large volume fluid infusion or catheter introduction to the central circulation

Manufacturer details

EUDAMED SRN
US-MF-000024256
Authorised representative
Teleflex Medical IE-AR-000015869

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)

See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →

Properties

  • Sterile
  • Contains Latex
  • Reprocessed
  • CMR Substance
  • Animal Tissues

Other properties (8)

  • Implantable: No
  • Reusable: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No