myCordella Handheld Patient Reader and Docking Station (includes myCordella Handheld Patient Reader and myCordella Docking Station)

Name: myCordella Handheld Patient Reader and Docking Station (includes myCordella Handheld Patient Reader and myCordella Docking Station)
Brand: Endotronix, Inc.
SKU: 00850008997013

UDI-DI 00850008997013Basic 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)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/mycordella-handheld-patient-reader-and-docking-station-inclu-7013 · UDI page: /udi/00850008997013

All devices from Endotronix, Inc.

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