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Bioptimal Central Venous Catheter and Catheterization Kit

by Bioptimal International PTE. LTD. United States EUDAMED

Ref 25-000004-90Model CVN-702-16

EMDN C01020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483505568 Basic UDI-DIDate8 Aug 2024RegisteredStatusActive

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
Central Venous Catheter and Catheterization Kit
Model / Reference
CVN-702-16, 25-000004-90
Primary DI / UDI-DI
08886483505568
Basic UDI-DI
B-08886483505568
EMDN Code
C01020202 Central venous double-lumen catheters, non-tunneled
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

Related devices

Category: Central venous catheterization kit, short-term

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Properties & raw data

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

Sources (1)

  • EUDAMED e49f0ec1-8673-44f6-9e71-82752a092613 61 fields · synced 22 Oct 2026