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BioFreedom

by Biosensors Europe SA 20 variants

Ref BFR1-4028Model BFR1-2208

Active European Union

CE MDR CE MDD

Valid until

1 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2274451CE02 Date22 Oct 2025IssuedStatusActive expires 1 Nov 2029
European UnionCE/MDD NumberB-08888893014821 Basic UDI-DI 08888893014821UDI-DIDate15 Mar 2023RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2274451TD04 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    22 Oct 2025
    Expires
    1 Oct 2030
  • 2274451CE02 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    22 Oct 2025
    Expires
    1 Nov 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
BioFreedom Drug Coated Coronary Stent System
Device Name
BioFreedom
Model / Reference
BFR1-4028, BFR1-2208
Primary DI / UDI-DI
08888893014821
Basic UDI-DI
B-08888893014821, 8888893BFR1FW
EMDN Code
P070402010302 Coronary drug eluting stents (des) without polymers
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000015764
Authorised representative
NVT GmbH DE-AR-000006441

Other devices from Biosensors Europe SA

See all devices from Biosensors Europe SA →

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No