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Acent-2

by Global Medikit Limited 72 variants

Ref 4814152GModel 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)

Active European Union

CE MDR

Valid until

22 Jun 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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), 4814152G
Primary DI / UDI-DI
08903545076337
Basic UDI-DI
8903545GMLCVC003GZ
EMDN Code
C01020202 Central venous double-lumen catheters, non-tunneled
Device Class
Class III
EU 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