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RISE SC Semi-Compliant PTCA Balloon Catheter

by Biosensors Europe SA 71 variants

Ref RSC-50020Model RSC-10008

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8888893RSCV4 Basic UDI-DI 08888893031576UDI-DIDate13 May 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2274451TD01 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    11 Dec 2024
    Expires
    1 Dec 2029
  • 2274451CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    2 Apr 2026
    Expires
    1 Nov 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
RSC-10008, RSC-50020
Primary DI / UDI-DI
08888893031576
Basic UDI-DI
8888893RSCV4
EMDN Code
C010401020101 Ptca balloon dilation catheters
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

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