Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

LUX-Dx™

UDI-DI 00802526607110Basic UDI-DI 01915060000000000000219MX

Class III · MDR · Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation

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Identification

Model: —
EMDN: J010201
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 749618

EU technical documentation assessment · unknown

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

Valid from 2026-09-18 · Expiry 2027-08-23

Scope not stated in certificate data.

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

Manufacturer

Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation

SRN US-MF-000010993

US · Saint Paul

manufacturer

Authorised representative: Guidant Europe NV/SA; Boston Scientific (BE-AR-000008410)

Related UDI-DIs

LUX-Dx II™ 00802526623608
LUX-DX II+™ 00802526623707

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lux-dxtm-7110 · UDI page: /udi/00802526607110

All devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation

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