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Acent-1

by Global Medikit Limited 16 variants

Ref 4766132GModel 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)

Acent-1 (4766132G) is a Class III device made by Global Medikit Limited, registered in EUDAMED on 10 Jul 2024 (Basic UDI-DI 8903545GMLCVC003GZ) with CE/MDR certificate G70 113499 0006 valid until 22 Jun 2028, active as of 23 Oct 2026.

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

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

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

3 dated events

  1. Registered EUDAMED 8903545GMLCVC003GZ
  2. Certificate issued EUDAMED G70 113499 0006
  3. Certificate expires EUDAMED G70 113499 0006

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  • Withdrawn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), 4766132G
Primary DI / UDI-DI
08903545073978
Basic UDI-DI
8903545GMLCVC003GZ
EMDN code
C01020203 Central venous multi-lumen (>2) catheters, non-tunneled
Device class
Class III
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
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

Similar devices in this category

Other devices filed under CENTRAL I.V. CATHETERS.

Other devices from Global Medikit Limited

See all devices from Global Medikit Limited →

Properties

  • Supplied sterile
  • Administering medicine
Other properties (12, all answered No)