Certificate valid

Snapshot 2026-10-25 · Link to EUDAMED

ACUITY™

UDI-DI 00802526626784Basic UDI-DI 01915060000000000000391NC

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

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Identification

Model: —
EMDN: C0104010202
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 790667

EU technical documentation assessment · valid

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

Valid from 2024-04-02 · Expiry 2029-04-01

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)

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Showing 12 of 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acuitytm-6784 · UDI page: /udi/00802526626784

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

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