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Bioptimal Bipolar Pacing Catheter

by Bioptimal International PTE. LTD. United States EUDAMED

Ref BP-0006-011Model BP2502CS-10（CROATIA)(PLUG-B)

EMDN C020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483512474 Basic UDI-DIDate29 Jan 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 22 Oct 2026

Device Name
Bipolar Pacing Catheter
Model / Reference
BP2502CS-10（CROATIA)(PLUG-B), BP-0006-011
Primary DI / UDI-DI
08886483512474
Basic UDI-DI
B-08886483512474
EMDN Code
C020201 Temporary endocardial leads
Device Class
Class III
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
SG-MF-000010306
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bioptimal International Pte. Ltd.

See all devices from Bioptimal International Pte. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c73da596-98da-43ab-a264-88e3fceba83a 61 fields · synced 22 Oct 2026