Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Cordella Pulmonary Artery Sensor System Calibration Equipment

UDI-DI 00850008997136Basic UDI-DI 0850008997CORDELLAXA

Class III · MDR · Endotronix, Inc.

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Identification

Model: —
EMDN: J010701
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: Yes
Measuring function: Yes
Reusable surgical: No

Certificates

MDR 804297

EU technical documentation assessment · unknown

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

Valid from 2026-08-03 · Expiry 2030-06-03

Scope not stated in certificate data.

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

Manufacturer

Endotronix, Inc.

SRN US-MF-000043257

US · Naperville, Illinois

manufacturer

Authorised representative: Edwards Lifesciences GmbH (DE-AR-000006184)

Related UDI-DIs

Cordella Data Analysis Platform (CDAP) 00850008997051
Cordella Sensor Delivery Kit (includes Cordella Sensor and Cordella Delivery System) 00850008997006
myCordella Handheld Patient Reader and Docking Station (includes myCordella Handheld Patient Reader and myCordella Docking Station) 00850008997013

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cordella-pulmonary-artery-sensor-system-calibration-equipmen-7136 · UDI page: /udi/00850008997136

All devices from Endotronix, Inc.

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