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Bioptimal Vascular Introducer Kit

by Bioptimal International PTE. LTD. FDA registration: Singapore EUDAMED

Ref 24-000019-00Model CPIK 8F EMDN C0599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483504677 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Vascular Introducer Kit
Model / Reference
CPIK 8F, 24-000019-00
Primary DI / UDI-DI
08886483504677
Basic UDI-DI
B-08886483504677
EMDN Code
C0599 Cardiovascular introducer sheaths - other
Device Class
Class IIa
Market of Registration
Italy

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
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 08886483504677|B-08886483504677 61 fields · synced 24 Oct 2026