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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

BioMatrix Alpha Drug Eluting Coronary Stent System

UDI-DI 08888893018904Basic UDI-DI 8888893BMX6HV

Class III · MDR · Biosensors Europe SA

Identification
Model
BMX6-2209
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

TD745.151

EU technical documentation assessment · valid

Notified body: National Standards Authority of Ireland (NSAI) (0050)

Valid from 2026-03-13 · Expiry 2031-03-12

Scope not stated in certificate data.

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

745.151

EU quality management system · valid

Notified body: National Standards Authority of Ireland (NSAI) (0050)

Valid from 2026-03-13 · Expiry 2031-03-12

Scope not stated in certificate data.

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

Manufacturer

Biosensors Europe SA

SRN CH-MF-000015764

CH · Morges

manufacturer

Authorised representative: NVT GmbH (DE-AR-000006441)

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Canonical device page: /device/biomatrix-alpha-8904 · UDI page: /udi/08888893018904

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