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UDI Compass

EMBLEM™

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00802526599309Basic UDI-DI 01915060000000000000005MA

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

Identification

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

Certificates

MDR 743490

EU technical documentation assessment · valid

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

Valid from 2026-05-24 · Expiry 2031-05-24

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

NameUDI-DICertificate
EMBLEM™00802526591914
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/emblemtm-9309 · UDI page: /udi/00802526599309

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