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Acent-3
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref 4795132GModel 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)
Identity
- Trade Name
- Acent-3 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) EUDAMED4795132G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545074876 EUDAMED
- Basic UDI-DI
- 8903545GMLCVC003GZ EUDAMED
- EMDN Code
- C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Central venous catheterization kit, short-term
Acent-3 by Global Medikit Limited — Class III — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Central venous catheterization kit, short-term.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193158 | Class III | Active |
| 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 (2)
- EUDAMED 42718bed-a17f-4109-8420-f368bea12472 61 fields · synced Jun 18, 2026
- FDA 510(k) K193158 1 fields · synced May 18, 2026