Identity
- Trade Name
- OXIKIT PLUS 3661 EUDAMED
- Device Name
- OXIKIT PLUS - Oxygen Distribution Kit EUDAMED
- Model / Reference
- OXIKIT PLUS EUDAMEDOXIP3661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052400881774 EUDAMED
- Basic UDI-DI
- 805240088OXIJA EUDAMED
- Direct Marketing DI
- 08052400881774 EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxikit Plus 3661 by Oscar Boscarol Srl — Class IIb — 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 | 805240088OXIJA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oscar Boscarol Srl
- EUDAMED SRN
- IT-MF-000007810
Sources (1)
- EUDAMED b23c11cc-e719-457c-9e95-885af9a4f01c 61 fields · synced Jul 11, 2026