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Polysite 3000 Eco Ecg Port Pur 6, 9f Pps Ct
EUDAMEDClass III (EU MDR)
Ref A3017ISP19
Identity
- Trade Name
- POLYSITE 3000 ECO ECG PORT PUR 6,9F PPS CT EUDAMED
- Device Name
- POLYSITE 2000 ECO ECG PORT PUR 6F C/PPS CT EUDAMED
- Model / Reference
- A3017ISP19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059602732705 EUDAMED
- Basic UDI-DI
- 805960273D01A2000ISP-193D 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, ago di Huber e kit per impianto ecoguidato e verifica del posizionamento tramite ECG intracavitario EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Polysite 3000 Eco Ecg Port Pur 6, 9f Pps Ct 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-193D | Class III | Active |
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Manufacturer
- Manufacturer
- Vygon Italia Srl
- EUDAMED SRN
- IT-PR-000012626
Sources (1)
- EUDAMED f17d2f50-2ea8-4805-bd0b-7b16bfd7a594 61 fields · synced Jul 9, 2026