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Rise Nc

by Biosensors Europe SA 57 variants

Ref NCB-32515Model NCB-20008

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2274451TD05 Date28 Apr 2026IssuedStatusActive expires 1 Apr 2031
European UnionCE/MDD NumberB-08888893024943 Basic UDI-DI 08888893024943UDI-DIDate15 Jun 2023RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2274451TD05 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    28 Apr 2026
    Expires
    1 Apr 2031
    Reason
    Other
  • 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
RISE NC Non-Compliant PTCA Balloon Catheter
Device Name
Rise Nc
Model / Reference
NCB-32515, NCB-20008
Primary DI / UDI-DI
08888893024943
Basic UDI-DI
B-08888893024943, 8888893NCBSW
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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

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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