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UDI Compass

Balloon Wedge Pressure Catheter

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 10801902206418Basic UDI-DI 08019020000000000000136KJ

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Class III · MDR · Arrow International LLC (Subsidiary of Teleflex Incorporated)

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No

Certificates

MDR 751821

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-10-28 · Expiry 2029-10-13

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Arrow International LLC (Subsidiary of Teleflex Incorporated)

SRN US-MF-000024256

US · Morrisville, NC

manufacturer

Authorised representative: Teleflex Medical (IE-AR-000015869)

Related UDI-DIs

NameUDI-DICertificate
Balloon Wedge Pressure Catheter10801902206371
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

Balloon Wedge Pressure Catheter10801902206388
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

Balloon Wedge Pressure Catheter10801902206432
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/balloon-wedge-pressure-catheter-6418 · UDI page: /udi/10801902206418

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