Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

BioFreedom Drug Coated Coronary Stent System

UDI-DI 08888893028651Basic UDI-DI 8888893BFR1FW

Class III · MDR · Biosensors Europe SA

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Identification

Model: BFR1-2208
EMDN: P070402010302
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

2274451TD04

EU technical documentation assessment · valid

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

Valid from 2025-10-22 · Expiry 2030-10-01

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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Showing 12 of 31 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/biofreedom-8651 · UDI page: /udi/08888893028651

All devices from Biosensors Europe SA

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