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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Amulet™

UDI-DI 05415067055460Basic UDI-DI 5414734LAS0052HJ

Class III · MDR · Abbott Medical

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

MDR 842924

EU technical documentation assessment · valid

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

Valid from 2026-08-05 · Expiry 2031-08-04

Scope not stated in certificate data.

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

Manufacturer

Abbott Medical

SRN US-MF-000016948

US · Plymouth, MN

manufacturer

Authorised representative: Abbott Medical (BE-AR-000008744)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/amulettm-5460 · UDI page: /udi/05415067055460

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