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Bioptimal Central Venous Catheter and Catheterization Kit

by Bioptimal International PTE. LTD. EUDAMED

Active European Union

Ref 25-000007-33Model CVN-401-16

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483531437 Basic UDI-DIDate10 Apr 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  • Withdrawn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

Device Name
Central Venous Catheter and Catheterization Kit
Model / Reference
CVN-401-16, 25-000007-33
Primary DI / UDI-DI
08886483531437
Basic UDI-DI
B-08886483531437
EMDN Code
C01020201 Central i.v. single-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

  • 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