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Leader Flex Ecg Ped. Pack 03 - 20g 8cm
EUDAMEDClass IIa (EU MDR)
Ref A1211.0803
Identity
- Trade Name
- LEADER FLEX ECG PED. PACK 03 - 20G 8CM EUDAMED
- Device Name
- LEADER FLEX ECG PED. PACK 03 - 18G 10CM EUDAMED
- Model / Reference
- A1211.0803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059602733801 EUDAMED
- Basic UDI-DI
- 805960273D01A1211-34N EUDAMED
- EMDN Code
- C01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Kit per l’impianto di un catetere venoso centrale pediatrico monolume con verifica del posizionamento con tecnica ECG e fissaggio sutureless EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Central venous catheterization kit, short-term
Leader Flex Ecg Ped. Pack 03 - 20g 8cm by Vygon Italia Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805960273D01A1211-34N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vygon Italia Srl
- EUDAMED SRN
- IT-PR-000012626
Sources (1)
- EUDAMED 97ad5b4e-8371-4727-83a5-665d746bb077 61 fields · synced Jul 23, 2026