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BioMatrix Alpha

by Biosensors Europe SA 24 variants

Ref BMX6-2709Model BMX6-2209

Active European Union

CE MDR CE MDD

Valid until

12 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier National Standards Authority of Ireland (NSAI)

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number745.151 Date13 Mar 2026IssuedStatusActive expires 12 Mar 2031
European UnionCE/MDD NumberB-08888893018768 Basic UDI-DI 08888893018768UDI-DIDate9 Jun 2023RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 745.151 Active

    Quality management system EU MDR

    Certifier
    National Standards Authority of Ireland (NSAI) 0050
    Issued
    13 Mar 2026
    Expires
    12 Mar 2031
  • TD745.151 Active

    Technical documentation EU MDR

    Certifier
    National Standards Authority of Ireland (NSAI) 0050
    Issued
    13 Mar 2026
    Expires
    12 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
BioMatrix Alpha Drug Eluting Coronary Stent System
Device Name
BioMatrix Alpha
Model / Reference
BMX6-2709, BMX6-2209
Primary DI / UDI-DI
08888893018768
Basic UDI-DI
B-08888893018768, 8888893BMX6HV
EMDN Code
P070402010301 Coronary drug eluting stents (des) with polymers
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

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

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See all devices from Biosensors Europe SA →

Properties

  • Sterile
  • Implantable
  • CMR Substance
  • Incorporates Medicinal Product

Other properties (9)

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