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Polysite Standard Port Cb Pack Sil 7, 2f
EUDAMEDClass III (EU MDR)
Ref A4008ISP21
Identity
- Trade Name
- POLYSITE STANDARD PORT CB PACK SIL 7,2F EUDAMED
- Device Name
- POLYSITE MICRO PORT CB PACK PUR 5F EUDAMED
- Model / Reference
- A4008ISP21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059602732606 EUDAMED
- Basic UDI-DI
- 805960273D01A2000ISP-212Y EUDAMED
- EMDN Code
- C01020401 SUBCUTANEOUS IMPLANTABLE VENOUS ACCESS PORT SYSTEMS, SINGLE-CHAMBER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Kit con CVC con camera impiantabile, colla cianoacrilica e accessoru per impianto ecoguidato e verifica del posizionamento tramite ECG intracavitario EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Polysite Standard Port Cb Pack Sil 7, 2f by Vygon Italia Srl — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 805960273D01A2000ISP-212Y | Class III | Active |
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Manufacturer
- Manufacturer
- Vygon Italia Srl
- EUDAMED SRN
- IT-PR-000012626
Sources (1)
- EUDAMED 12a94364-1279-40ff-bbbc-775c09710302 61 fields · synced Jul 14, 2026