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Acent-2

by Global Medikit Limited EUDAMED

Active European Union

Ref 4815132GModel Central Venous Catheter Set (Single Lumen); Central Venous Catheter Set (Double lumen); Central Venous Catheter Set (Triple lumen); Central Venous Catheter Set (Four lumen); Central Venous Catheter Set (Five lumen)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 113499 0006 Date3 Mar 2026IssuedStatusActive expires 22 Jun 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Central Venous Catheter Set
Model / Reference
Central Venous Catheter Set (Single Lumen), Central Venous Catheter Set (Double lumen), Central Venous Catheter Set (Triple lumen), Central Venous Catheter Set (Four lumen), Central Venous Catheter Set (Five lumen), 4815132G
Primary DI / UDI-DI
08903545076467
Basic UDI-DI
8903545GMLCVC003GZ
EMDN Code
C01020202 Central venous double-lumen catheters, non-tunneled
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000013635
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Central venous catheterization kit, short-term

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Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No