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BioMC Coronary Microcatheter

by Biosensors Europe SA EUDAMED

Active European Union

Ref MC1-135

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8888893MC1RR Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2274451TD03 Active

    Technical documentation EU MDR

    Notified body
    0344
    Issued
    7 Dec 2024
    Expires
    1 Dec 2029
  • 2274451CE01 Active Supplemented

    Quality management system EU MDR

    Notified body
    0344
    Issued
    2 Apr 2026
    Expires
    1 Nov 2029
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
MC1-135
Primary DI / UDI-DI
08888893032696
Basic UDI-DI
8888893MC1RR
EMDN Code
C01040199 Cardiac angiography devices - other
Device Class
Class III
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

Other properties (12)

  • Implantable: No
  • 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
  • Incorporates Medicinal Product: No