Identity
- Trade Name
- SMART MINIMID BASIC PACK 3F 8CM EUDAMED
- Device Name
- SMART MIDLINE BASIC PACK 2F 20CM EUDAMED
- Model / Reference
- A128.130802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059602734730 EUDAMED
- Basic UDI-DI
- 805960273D01A128-2VH EUDAMED
- EMDN Code
- C010102 PERIPHERAL I.V. CATHETER SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Kit con catetere SmartMidline CT-rated e accessori per il posizionamento e fissaggio EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Smart Minimid Basic Pack 3f 8cm by Vygon Italia Srl — Class IIa — 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 | 805960273D01A128-2VH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vygon Italia Srl
- EUDAMED SRN
- IT-PR-000012626
Sources (1)
- EUDAMED a026b76f-1e3a-471b-b49b-9335eca2f5fd 61 fields · synced Jul 13, 2026