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OptiCross™

by Boston Scientific Corporation United States EUDAMED

Ref H7493932801350

EMDN C0104020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08714729997153 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
OC35 8F Paper Dfu
Model / Reference
H7493932801350
Primary DI / UDI-DI
08714729997153
Basic UDI-DI
B-08714729997153
EMDN Code
C0104020102 Intravascular ultrasound catheters
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08714729997153|B-08714729997153 61 fields · synced 24 Oct 2026