Acent-2

EUDAMED

Class III (EU MDR)

Ref 4787162GModel 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)

by Global Medikit Limited

Identity

Trade Name: Acent-2 EUDAMED
Device Name: Central Venous Catheter Set EUDAMED
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) EUDAMED
4787162G EUDAMED

Identifiers

Primary DI / UDI-DI: 08903545074517 EUDAMED
Basic UDI-DI: 8903545GMLCVC003GZ EUDAMED
EMDN Code: C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED

Classification

Device Class: Class III EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Central venous catheterization kit, short-term

Acent-2 by Global Medikit Limited — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Central venous catheterization kit, short-term.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	8903545GMLCVC003GZ	Class III	Active

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Manufacturer

Manufacturer: Global Medikit Limited
EUDAMED SRN: IN-MF-000013635
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (1)

EUDAMED a31eb6a9-5d7b-4efa-92dd-c7ac3c51aa7a 61 fields · synced Jun 19, 2026