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Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for…

EUDAMED

Class IIb (EU MDR)

Ref CI-09800

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Identity

Trade Name
Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters EUDAMED
Device Name
Multi-Lumen Access Catheter (MAC) & Percutaneous Sheath Introducer (PSI) Product EUDAMED
Model / Reference
CI-09800 EUDAMED

Identifiers

Primary DI / UDI-DI
10801902200089 EUDAMED
Basic UDI-DI
08019020000000000000103K3 EUDAMED
EMDN Code
C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMED

Reprocessed

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Vascular catheter introduction set, nonimplantable

Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port for… by Arrow International LLC (Subsidiary of Teleflex Incorporated) — Class IIb…

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Arrow International LLC (Subsidiary of Teleflex Incorporated)
EUDAMED SRN
US-MF-000024256
Authorised Representative
Teleflex Medical IE-AR-000015869

Sources (1)

  • EUDAMED 4fd7a357-7691-4262-841b-c7a598e48ad5 61 fields · synced Oct 6, 2026