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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

BioFreedom Ultra Drug Coated Coronary Stent System

UDI-DI 08888893024189Basic UDI-DI 8888893BFC1EH

Class III · MDR · Biosensors Europe SA

Identification
Model
BFC1-2209
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2274451TD02

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-11-26 · Expiry 2029-11-01

Scope not stated in certificate data.

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

2274451CE02

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-10-22 · Expiry 2029-11-01

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/biofreedom-ultra-4189 · UDI page: /udi/08888893024189

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