← Back to catalogue
SMART FLOW KIT NIV Extra Small "RED"
EUDAMEDClass IIa (EU MDR)
Ref 12898A08Model SMART FLOW KIT NIV Extra Small "RED"
by GINEVRI srl
Identity
- Trade Name
- SMART FLOW KIT NIV Extra Small "RED" EUDAMED
- Device Name
- SMART FLOW KIT NIV EUDAMED
- Model / Reference
- SMART FLOW KIT NIV Extra Small "RED" EUDAMED12898A08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360273 EUDAMED
- Basic UDI-DI
- B-08053847360273 EUDAMED
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SMART FLOW KIT NIV Extra Small "RED" by GINEVRI srl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053847360273 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED 66d2a395-8a54-482c-b3bf-20d910935d4b 61 fields · synced Jun 18, 2026