Identity
- Trade Name
- MAXFLO ECG GOLD PACK 4F EUDAMED
- Device Name
- MAXFLO ECG GOLD PACK 4F EUDAMED
- Model / Reference
- A8394.413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059602733207 EUDAMED
- Basic UDI-DI
- 805960273D01A8394-13HG EUDAMED
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Catetere PICC CT-rated con kit per posizionamento ecoguidato, massime barriere di protezione e verifica ECG EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Maxflo Ecg Gold Pack 4f 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 | 805960273D01A8394-13HG | Class III | Active |
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Manufacturer
- Manufacturer
- Vygon Italia Srl
- EUDAMED SRN
- IT-PR-000012626
Sources (1)
- EUDAMED 7d9ba186-6102-4dff-ad6b-a7c7497fd2ca 61 fields · synced Sep 30, 2026